A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT02341625
Collaborator
(none)
126
17
4
58.6
7.4
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
126 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
Actual Study Start Date
:
Jun 19, 2015
Actual Primary Completion Date
:
Feb 25, 2019
Actual Study Completion Date
:
May 7, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Ascending dose of BMS-986148 BMS-986148 Intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. Alternate dose and schedules may be explored. |
Drug: BMS-986148
|
| Experimental: Part 2: Expansion dose of BMS-986148 BMS-986148 Intravenous injection of Maximum tolerated dose (MTD) on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. |
Drug: BMS-986148
|
| Experimental: Part 3A: Ascending dose of BMS-986148 Set dose of nivolumab and BMS-986148 intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. |
Drug: BMS-986148
Biological: Nivolumab
Other Names:
|
| Experimental: Part 3B: Expansion dose of BMS-986148 Set dose of nivolumab and BMS-986148 intravenous injection at or below maximum tolerated dose on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. |
Drug: BMS-986148
Biological: Nivolumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events at Worst CTC Grade [From first dose to up to 100 days post last dose (Up to 6 months)]
Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
- Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline [From first dose to up to 100 days post last dose (Up to 6 months)]
Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
Secondary Outcome Measures
- Maximum Observed Serum Concentration (Cmax) [PK blood assessed on cycle 1, day 1]
Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
- Time of Maximum Observed Serum Concentration (Tmax) [PK blood assessed on cycle 1, day 1]
Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.
- Concentration at the End of a Dosing Interval (Ctau) [PK blood assessed on cycle 1, day 1]
Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
- Trough Observed Serum Concentration (Ctrough) [PK blood assessment include cycle 2-day 1 and cycle 1-day 8]
Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
- Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) [PK blood assessment include cycle 1-day 1]
Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
- Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) [PK blood assessment include cycle 1-day 1]
Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead
- Best Overall Response (BOR) [Up to 58 months]
Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Objective Response Rate (ORR) [Up to 58 months]
Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Duration of Response (DoR) [Up to 58 months]
Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
- Progression Free Survival (PFS) [Up to 58 months]
Progression Free Survival is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
- Progression Free Survival Rate (PFSR) at Week t [Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported]
Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
- Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times [Up to 58 months]
Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen
- Number of Participants With Anti-Drug Antibody (ADA) [Up to 58 months]
Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen. Data was not collected for this outcome measure.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
-
Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
-
Expected to have life expectancy of at least 3 months
-
Men and women 18 years old or older (or local age of majority)
-
Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
-
ECOG of 0 to 1
Exclusion Criteria:
-
Cancer metastases in the brain
-
Moderate eye disorders
-
Active infection or past hepatitis B or C infection
-
Major surgery less than 1 month before the start of the study
-
Uncontrolled heart disease
-
Impaired liver or bone marrow function
-
History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moores Cancer Center | La Jolla | California | United States | 92093-0698 |
| 2 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 3 | Local Institution - 0013 | Liverpool | New South Wales | Australia | 2170 |
| 4 | Local Institution - 0014 | Adelaide | South Australia | Australia | 5000 |
| 5 | Local Institution - 0004 | Clayton | Victoria | Australia | 3168 |
| 6 | Local Institution - 0015 | Nedlands | Western Australia | Australia | 6009 |
| 7 | Local Institution - 0008 | Gent | Oost-Vlaanderen | Belgium | 9000 |
| 8 | Local Institution - 0009 | Bruxelles | Belgium | 1200 | |
| 9 | Local Institution - 0002 | Edmonton | Alberta | Canada | T6G 1Z2 |
| 10 | Local Institution - 0003 | Toronto | Ontario | Canada | M5G 1Z5 |
| 11 | Local Institution - 0017 | Milan | Lombardia | Italy | 20141 |
| 12 | Local Institution - 0018 | Milano | Italy | 20133 | |
| 13 | Local Institution - 0016 | Rozzano (milano) | Italy | 20089 | |
| 14 | Local Institution - 0010 | Amsterdam | Netherlands | 1066 CX | |
| 15 | Local Institution - 0011 | Rotterdam | Netherlands | 3015 AA | |
| 16 | Local Institution - 0007 | Southampton | Hampshire | United Kingdom | SO16 6YD |
| 17 | Local Institution - 0006 | Glasgow | Lanarkshire | United Kingdom | G12 0YN |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02341625
Other Study ID Numbers:
- CA008-002
- 2014-002485-70
First Posted:
Jan 19, 2015
Last Update Posted:
Aug 18, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Period Title: Overall Study | ||||||||||
| STARTED | 2 | 2 | 3 | 8 | 8 | 10 | 51 | 8 | 4 | 30 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 2 | 2 | 3 | 8 | 8 | 10 | 51 | 8 | 4 | 30 |
Baseline Characteristics
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS 0.8MG/KG + Nivolumab Q3W | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Total of all reporting groups |
| Overall Participants | 2 | 2 | 3 | 8 | 8 | 10 | 51 | 8 | 4 | 30 | 126 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [Years] |
59.5
(0.7)
|
70.5
(0.7)
|
65.3
(5.8)
|
63.9
(5.4)
|
63.4
(5.1)
|
59.0
(16.0)
|
61.5
(9.5)
|
66.3
(8.6)
|
64.5
(9.1)
|
61.6
(9.4)
|
62.2
(9.4)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
0
0%
|
0
0%
|
2
66.7%
|
3
37.5%
|
3
37.5%
|
3
30%
|
31
60.8%
|
3
37.5%
|
2
50%
|
12
40%
|
59
46.8%
|
| Male |
2
100%
|
2
100%
|
1
33.3%
|
5
62.5%
|
5
62.5%
|
7
70%
|
20
39.2%
|
5
62.5%
|
2
50%
|
18
60%
|
67
53.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||
| Hispanic or Latino |
0
0%
|
1
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
| Not Hispanic or Latino |
2
100%
|
1
50%
|
3
100%
|
8
100%
|
8
100%
|
10
100%
|
46
90.2%
|
8
100%
|
3
75%
|
25
83.3%
|
114
90.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
9.8%
|
0
0%
|
1
25%
|
5
16.7%
|
11
8.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
50%
|
0
0%
|
0
0%
|
1
12.5%
|
1
12.5%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
4
3.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
3.9%
|
0
0%
|
1
25%
|
0
0%
|
3
2.4%
|
| White |
1
50%
|
2
100%
|
3
100%
|
7
87.5%
|
7
87.5%
|
9
90%
|
46
90.2%
|
8
100%
|
3
75%
|
30
100%
|
116
92.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
5.9%
|
0
0%
|
0
0%
|
0
0%
|
3
2.4%
|
Outcome Measures
| Title | Number of Participants With Adverse Events at Worst CTC Grade |
|---|---|
| Description | Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen. |
| Time Frame | From first dose to up to 100 days post last dose (Up to 6 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 8 | 10 | 59 | 8 | 4 | 30 |
| Adverse Events (AEs) |
1
50%
|
2
100%
|
3
100%
|
8
100%
|
10
125%
|
59
590%
|
8
15.7%
|
4
50%
|
30
750%
|
| Serious Adverse Events (SAEs) |
1
50%
|
1
50%
|
1
33.3%
|
5
62.5%
|
4
50%
|
32
320%
|
6
11.8%
|
3
37.5%
|
21
525%
|
| AEs Leading to Discontinuation |
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
3
37.5%
|
11
110%
|
1
2%
|
0
0%
|
7
175%
|
| Deaths |
1
50%
|
2
100%
|
3
100%
|
5
62.5%
|
7
87.5%
|
38
380%
|
7
13.7%
|
4
50%
|
22
550%
|
| Title | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline |
|---|---|
| Description | Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03. |
| Time Frame | From first dose to up to 100 days post last dose (Up to 6 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 8 | 10 | 59 | 8 | 4 | 30 |
| Hemoglobin increase from baseline |
1
50%
|
1
50%
|
0
0%
|
3
37.5%
|
3
37.5%
|
20
200%
|
2
3.9%
|
1
12.5%
|
12
300%
|
| Hemoglobin decrease from baseline |
0
0%
|
0
0%
|
1
33.3%
|
1
12.5%
|
0
0%
|
3
30%
|
0
0%
|
0
0%
|
0
0%
|
| Platelet Count increase from baseline |
0
0%
|
0
0%
|
0
0%
|
3
37.5%
|
4
50%
|
14
140%
|
0
0%
|
1
12.5%
|
6
150%
|
| Platelet Count decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Leukocytes increase from baseline |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
2
25%
|
1
10%
|
1
2%
|
0
0%
|
2
50%
|
| Leukocytes decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
2%
|
0
0%
|
0
0%
|
| Neutrophils increase from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
3
30%
|
0
0%
|
0
0%
|
1
25%
|
| Neutrophils decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
| Lymphocytes increase from baseline |
1
50%
|
2
100%
|
1
33.3%
|
3
37.5%
|
6
75%
|
27
270%
|
6
11.8%
|
3
37.5%
|
19
475%
|
| Lymphocytes decrease from baseline |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
1
2%
|
0
0%
|
0
0%
|
| Absolute Neutrophil increase from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
3
30%
|
0
0%
|
0
0%
|
2
50%
|
| Absolute Neutrophil decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
| Alkaline Phosphatase (ALP) increase from baseline |
0
0%
|
1
50%
|
1
33.3%
|
6
75%
|
10
125%
|
46
460%
|
5
9.8%
|
4
50%
|
24
600%
|
| Alkaline Phosphatase (ALP) decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Aspartate Aminotransferase (AST) increase from baseline |
0
0%
|
1
50%
|
1
33.3%
|
6
75%
|
10
125%
|
53
530%
|
6
11.8%
|
4
50%
|
26
650%
|
| Aspartate Aminotransferase (AST) decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Alanine Aminotransferase (ALT) increase from baseline |
0
0%
|
0
0%
|
0
0%
|
7
87.5%
|
10
125%
|
50
500%
|
5
9.8%
|
3
37.5%
|
25
625%
|
| Alanine Aminotransferase (ALT) decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
| Bilirubin increase from baseline |
0
0%
|
1
50%
|
0
0%
|
2
25%
|
3
37.5%
|
16
160%
|
2
3.9%
|
2
25%
|
7
175%
|
| Bilirubin decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Creatinine increase from baseline |
0
0%
|
0
0%
|
1
33.3%
|
2
25%
|
2
25%
|
7
70%
|
1
2%
|
3
37.5%
|
5
125%
|
| Creatinine decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sodium increase from baseline |
0
0%
|
1
50%
|
1
33.3%
|
4
50%
|
4
50%
|
23
230%
|
1
2%
|
2
25%
|
17
425%
|
| Sodium decrease from baseline |
1
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Potassium increase from baseline |
1
50%
|
0
0%
|
0
0%
|
3
37.5%
|
5
62.5%
|
24
240%
|
1
2%
|
2
25%
|
9
225%
|
| Potassium decrease from baseline |
0
0%
|
1
50%
|
0
0%
|
0
0%
|
0
0%
|
3
30%
|
0
0%
|
0
0%
|
0
0%
|
| Calcium Total increase from baseline |
0
0%
|
0
0%
|
0
0%
|
5
62.5%
|
4
50%
|
17
170%
|
3
5.9%
|
1
12.5%
|
10
250%
|
| Calcium Total decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
| Calcium Corrected increase from baseline |
0
0%
|
0
0%
|
0
0%
|
2
25%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
| Calcium Corrected decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Phosphorus increase from baseline |
2
100%
|
0
0%
|
2
66.7%
|
3
37.5%
|
4
50%
|
24
240%
|
1
2%
|
2
25%
|
7
175%
|
| Phosphorus decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2%
|
0
0%
|
0
0%
|
| Magnesium increase from baseline |
0
0%
|
1
50%
|
1
33.3%
|
2
25%
|
4
50%
|
22
220%
|
1
2%
|
2
25%
|
5
125%
|
| Magnesium decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
30%
|
0
0%
|
0
0%
|
1
25%
|
| Glucose Fasting Serum increase from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
6
60%
|
0
0%
|
1
12.5%
|
5
125%
|
| Glucose Fasting Serum decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
1
25%
|
| Albumin increase from baseline |
0
0%
|
1
50%
|
0
0%
|
7
87.5%
|
8
100%
|
37
370%
|
6
11.8%
|
2
25%
|
19
475%
|
| Albumin decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Amylase increase from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
| Amylase decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Lipase increase from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
25%
|
| Lipase decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Creatine Kinase increase from baseline |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
9
90%
|
0
0%
|
0
0%
|
3
75%
|
| Creatine Kinase decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
| Uric Acid increase from baseline |
0
0%
|
0
0%
|
1
33.3%
|
1
12.5%
|
2
25%
|
6
60%
|
0
0%
|
2
25%
|
6
150%
|
| Uric Acid decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Maximum Observed Serum Concentration (Cmax) |
|---|---|
| Description | Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Time Frame | PK blood assessed on cycle 1, day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS 0.8MG/KG Q3W+Nivolumab Es | BMS 0.8MG/KG Q3W+Nivolumab Ex |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle | Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 8 | 10 | 8 | 49 | 8 | 4 | 11 | 17 |
| Total Antibody |
2.3
(31.4)
|
2.8
(7.6)
|
3.3
(76.7)
|
16.4
(47.2)
|
39.8
(24.5)
|
28.5
(14.0)
|
28.3
(22.5)
|
9.3
(21.3)
|
14.5
(22.3)
|
16.7
(19.7)
|
18.8
(22.4)
|
| Active Antibody-Drug Conjugate (ADC) |
2.0
(29.8)
|
2.2
(8.2)
|
2.6
(76.1)
|
15.8
(46.4)
|
40.0
(26.3)
|
27.0
(18.6)
|
27.5
(22.6)
|
8.8
(20.3)
|
13.6
(31.0)
|
15.3
(27.6)
|
17.8
(24.6)
|
| Unconjugated Tubulysin |
0.5
(NA)
|
0.2
(17.1)
|
0.4
(52.3)
|
0.4
(70.9)
|
0.3
(58.2)
|
0.1
(36.0)
|
0.4
(75.0)
|
0.2
(42.5)
|
0.2
(42.5)
|
| Title | Time of Maximum Observed Serum Concentration (Tmax) |
|---|---|
| Description | Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen. |
| Time Frame | PK blood assessed on cycle 1, day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS 0.8MG/KG Q3W+Nivolumab Es | BMS 0.8MG/KG Q3W+Nivolumab Ex |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle | Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 8 | 10 | 8 | 49 | 8 | 4 | 11 | 17 |
| Total Antibody |
2.2
|
2.2
|
3.9
|
4.0
|
3.9
|
4.1
|
4.0
|
4.0
|
3.8
|
1.1
|
4.0
|
| Active Antibody-Drug Conjugate (ADC) |
0.2
|
2.2
|
0.5
|
2.5
|
1.5
|
3.8
|
3.9
|
4.0
|
3.8
|
1.0
|
4.0
|
| Unconjugated Tubulysin |
25.5
|
120.2
|
167.3
|
168.8
|
166.1
|
168.2
|
166.7
|
165.1
|
166.5
|
| Title | Concentration at the End of a Dosing Interval (Ctau) |
|---|---|
| Description | Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Time Frame | PK blood assessed on cycle 1, day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS 0.8MG/KG Q3W+Nivolumab Es | BMS 0.8MG/KG Q3W+Nivolumab Ex |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle | Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 2 | 8 | 10 | 7 | 46 | 8 | 3 | 10 | 17 |
| Total Antibody |
0.0035
(112.0)
|
0.0333
(115.7)
|
0.8233
(131.8)
|
0.4426
(106.1)
|
1.4101
(101.8)
|
1.0917
(91.9)
|
1.1938
(98.7)
|
3.2035
(20.2)
|
3.8872
(46.1)
|
0.2133
(114.0)
|
0.7544
(83.5)
|
| Active Antibody-Drug Conjugate (ADC) |
0.0633
(141.3)
|
0.0058
(NA)
|
0.0309
(123.8)
|
0.3049
(110.0)
|
0.2121
(111.3)
|
0.1558
(123.4)
|
1.2705
(39.5)
|
1.9068
(59.1)
|
0.1119
(187.1)
|
0.0797
(103.7)
|
|
| Unconjugated Tubulysin |
0.1630
(0.9)
|
0.2590
(77.1)
|
0.1634
(48.2)
|
0.1388
(36.0)
|
0.3539
(75.0)
|
0.1330
(NA)
|
| Title | Trough Observed Serum Concentration (Ctrough) |
|---|---|
| Description | Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Time Frame | PK blood assessment include cycle 2-day 1 and cycle 1-day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS 0.8MG/KG Q3W+Nivolumab Es | BMS 0.8MG/KG Q3W+Nivolumab Ex |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle | Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 7 | 6 | 8 | 39 | 8 | 3 | 10 | 13 |
| Total Antibody |
0.1
(0.0)
|
0.1
(0.00)
|
0.1
(0.00)
|
0.79676
(92.4)
|
0.92146
(125.9)
|
1.23291
(81.7)
|
1.14568
(104.4)
|
3.20352
(20.2)
|
3.88717
(46.1)
|
0.33875
(122.1)
|
0.77912
(79.1)
|
| Active Antibody-Drug Conjugate (ADC) |
0.1
(0.0)
|
0.1
(0.00)
|
0.1
(0.00)
|
0.27671
(95.3)
|
0.21835
(152.7)
|
0.36894
(90.7)
|
0.31524
(111.4)
|
1.27047
(39.5)
|
1.90678
(59.1)
|
0.18096
(97.4)
|
0.24389
(81.0)
|
| Unconjugated Tubulysin |
0.00005
(0.0)
|
0.00005
(0.0)
|
0.00005
(0.0)
|
0.00005
(0.0)
|
0.00007
(66.6)
|
0.00009
(127.6)
|
0.00006
(80.7)
|
0.00006
(64.7)
|
0.00018
(104.0)
|
0.00005
(0.0)
|
0.00005
(40.8)
|
| Title | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) |
|---|---|
| Description | Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Time Frame | PK blood assessment include cycle 1-day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab | BMS 0.8MG/KG Q3W+Nivolumab Ex |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 8 | 10 | 8 | 51 | 8 | 4 | 11 | 19 |
| Total Antibody |
152.6
(31.6)
|
232.5
(17.5)
|
129.6
(131.3)
|
1979.5
(69.6)
|
5399.8
(40.1)
|
4285.7
(29.3)
|
3472.6
(47.1)
|
858.0
(22.9)
|
1278.8
(35.1)
|
1815.8
(43.4)
|
2611.3
(33.5)
|
| Active Antibody-Drug Conjugate (ADC) |
88.6
(48.7)
|
70.7
(42.9)
|
60.8
(136.2)
|
1042.1
(68.6)
|
3083.6
(32.3)
|
2493.1
(25.1)
|
1984.7
(45.7)
|
565.4
(30.3)
|
927.3
(38.7)
|
1059.0
(44.8)
|
1447.5
(36.2)
|
| Unconjugated Tubulysin |
49.6
(NA)
|
29.6
(42.8)
|
80.1
(73.4)
|
197.0
(59.4)
|
42.3
(80.4)
|
9.3
(73.0)
|
42.5
(84.3)
|
25.5
(58.8)
|
17.7
(110.3)
|
| Title | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) |
|---|---|
| Description | Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead |
| Time Frame | PK blood assessment include cycle 1-day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS 0.8MG/KG Q3W+Nivolumab Es | BMS 0.8MG/KG Q3W+Nivolumab Ex |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle | Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 2 | 8 | 10 | 7 | 46 | 8 | 3 | 10 | 17 |
| Total Antibody |
179.3
(34.8)
|
265.7
(13.3)
|
344.6
(98.5)
|
2059.3
(68.7)
|
5318.6
(36.9)
|
4316.1
(28.8)
|
4159.4
(39.5)
|
858.0
(22.9)
|
1533.5
(19.2)
|
1839.0
(45.4)
|
2689.9
(34.0)
|
| Active Antibody-Drug Conjugate (ADC) |
109.0
(35.2)
|
371.6
(NA)
|
1098.7
(67.5)
|
3246.0
(36.6)
|
2507.2
(24.7)
|
2271.7
(40.1)
|
565.4
(30.3)
|
1063.9
(32.2)
|
1094.9
(48.0)
|
1478.1
(36.6)
|
|
| Unconjugated Tubulysin |
173.4
(48.2)
|
197.0
(59.4)
|
148.9
(30.3)
|
9.3
(73.0)
|
42.5
(84.3)
|
102.4
(NA)
|
| Title | Best Overall Response (BOR) |
|---|---|
| Description | Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Time Frame | Up to 58 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric) |
| Arm/Group Title | BMS-986148 Mesothelioma | BMS-986148+Nivolumab Mesothelioma | BMS-986148 Ovarian | BMS-986148+Nivolumab Ovarian | BMS-986148 Pancreatic | BMS-986148+Nivolumab Pancreatic | BMS-986148 NSCLC | BMS-986148+Nivolumab NSCLC | BMS-986148 Gastric | BMS-986148+Nivolumab Gastric |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 25 | 13 | 22 | 2 | 18 | 6 | 4 | 2 | 3 | 1 |
| Complete Response (CR) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Partial Response (PR) |
1
50%
|
3
150%
|
2
66.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Stable Disease (SD) |
13
650%
|
8
400%
|
11
366.7%
|
2
25%
|
4
50%
|
1
10%
|
1
2%
|
1
12.5%
|
1
25%
|
0
0%
|
| Progressive Disease (PD) |
7
350%
|
1
50%
|
7
233.3%
|
0
0%
|
11
137.5%
|
2
20%
|
2
3.9%
|
1
12.5%
|
2
50%
|
1
3.3%
|
| Title | Objective Response Rate (ORR) |
|---|---|
| Description | Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Time Frame | Up to 58 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric) |
| Arm/Group Title | BMS-986148 Mesothelioma | BMS-986148+Nivolumab Mesothelioma | BMS-986148 Ovarian | BMS-986148+Nivolumab Ovarian | BMS-986148 Pancreatic | BMS-986148+Nivolumab Pancreatic | BMS-986148 NSCLC | BMS-986148+Nivolumab NSCLC | BMS-986148 Gastric | BMS-986148+Nivolumab Gastric |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 25 | 13 | 22 | 2 | 18 | 6 | 4 | 2 | 3 | 1 |
| Number (95% Confidence Interval) [Percentage of participants] |
4.0
200%
|
23.1
1155%
|
9.1
303.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Duration of Response (DoR) |
|---|---|
| Description | Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). |
| Time Frame | Up to 58 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All response evaluable participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric). |
| Arm/Group Title | BMS-986148 Mesothelioma | BMS-986148+Nivolumab Mesothelioma | BMS-986148 Ovarian | BMS-986148+Nivolumab Ovarian | BMS-986148 Pancreatic | BMS-986148+Nivolumab Pancreatic | BMS-986148 NSCLC | BMS-986148+Nivolumab NSCLC | BMS-986148 Gastric | BMS-986148+Nivolumab Gastric |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Median (Full Range) [Months] |
29.7
|
8.97
|
NA
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | Progression Free Survival is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). |
| Time Frame | Up to 58 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric). |
| Arm/Group Title | BMS-986148 Mesothelioma | BMS-986148+Nivolumab Mesothelioma | BMS-986148 Ovarian | BMS-986148+Nivolumab Ovarian | BMS-986148 Pancreatic Part 1B | BMS-986148 Pancreatic | BMS-986148+Nivolumab Pancreatic | BMS-986148 NSCLC | BMS-986148+Nivolumab NSCLC | BMS-986148 Gastric | BMS-986148+Nivolumab Gastric |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 25 | 13 | 22 | 2 | 7 | 11 | 6 | 4 | 2 | 3 | 1 |
| Median (95% Confidence Interval) [Months] |
2.56
|
5.19
|
2.79
|
NA
|
1.64
|
NA
|
1.66
|
1.49
|
NA
|
NA
|
NA
|
| Title | Progression Free Survival Rate (PFSR) at Week t |
|---|---|
| Description | Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). |
| Time Frame | Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric). |
| Arm/Group Title | BMS-986148 Mesothelioma | BMS-986148+Nivolumab Mesothelioma | BMS-986148 Ovarian | BMS-986148+Nivolumab Ovarian | BMS-986148 Pancreatic Part 1B | BMS-986148 Pancreatic | BMS-986148+Nivolumab Pancreatic | BMS-986148 NSCLC | BMS-986148+Nivolumab NSCLC | BMS-986148 Gastric | BMS-986148+Nivolumab Gastric |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer. | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 25 | 13 | 22 | 2 | 7 | 11 | 6 | 4 | 2 | 3 | 1 |
| 4 months |
0.35
17.5%
|
0.65
32.5%
|
0.40
13.3%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| 6 months |
0.30
15%
|
0.47
23.5%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Title | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times |
|---|---|
| Description | Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen |
| Time Frame | Up to 58 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS 1.2MG/KG Q3W Ex | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 2 | 2 | 3 | 8 | 10 | 8 | 51 | 8 | 4 | 30 |
| <= 30 msec, |
1
50%
|
2
100%
|
2
66.7%
|
6
75%
|
9
112.5%
|
8
80%
|
37
72.5%
|
5
62.5%
|
3
75%
|
23
76.7%
|
| >30 - <= 60 msec |
1
50%
|
0
0%
|
1
33.3%
|
2
25%
|
1
12.5%
|
0
0%
|
12
23.5%
|
3
37.5%
|
1
25%
|
7
23.3%
|
| > 60 msec |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
3.9%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Anti-Drug Antibody (ADA) |
|---|---|
| Description | Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen. Data was not collected for this outcome measure. |
| Time Frame | Up to 58 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All ADA evaluable participants |
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab | BMS 1.2MG/KG Q3W Ex |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | From first dose to 100 days post last dose (Up to 6 months) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||
| Arm/Group Title | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab | |||||||||
| Arm/Group Description | Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | |||||||||
All Cause Mortality |
||||||||||||||||||
| BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/2 (50%) | 2/2 (100%) | 3/3 (100%) | 5/8 (62.5%) | 7/10 (70%) | 38/59 (64.4%) | 7/8 (87.5%) | 4/4 (100%) | 22/30 (73.3%) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/2 (50%) | 1/2 (50%) | 1/3 (33.3%) | 5/8 (62.5%) | 4/10 (40%) | 32/59 (54.2%) | 6/8 (75%) | 3/4 (75%) | 21/30 (70%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Atrial fibrillation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Atrial flutter | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Cardiac failure | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Cardio-respiratory arrest | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pericardial effusion | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pericarditis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Tachycardia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 2/10 (20%) | 3/59 (5.1%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Ascites | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 3/59 (5.1%) | 0/8 (0%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Diarrhoea | 1/2 (50%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Duodenal obstruction | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Dysphagia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Gastrointestinal obstruction | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Ileus | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Ileus paralytic | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Impaired gastric emptying | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Intestinal obstruction | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Intestinal perforation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Intra-abdominal haemorrhage | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Nausea | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Rectal haemorrhage | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Small intestinal obstruction | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Subileus | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Vomiting | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| General disorders | ||||||||||||||||||
| Chest pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Infusion site extravasation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Malaise | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Non-cardiac chest pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Performance status decreased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pyrexia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Hepatobiliary disorders | ||||||||||||||||||
| Bile duct obstruction | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Bile duct stenosis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Cholangitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Drug-induced liver injury | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Hepatitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Hyperbilirubinaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Immune-mediated hepatitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Jaundice | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Abdominal infection | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Lymphangitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Peritonitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pneumonia | 1/2 (50%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 1/8 (12.5%) | 0/4 (0%) | 4/30 (13.3%) | |||||||||
| Sepsis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Subdural haematoma | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Toxicity to various agents | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Investigations | ||||||||||||||||||
| Blood creatinine increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Myocardial necrosis marker increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Transaminases increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Dehydration | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Hypoglycaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Hyponatraemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Arthralgia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Back pain | 1/2 (50%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Muscular weakness | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Musculoskeletal chest pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Malignant neoplasm progression | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 13/59 (22%) | 2/8 (25%) | 2/4 (50%) | 8/30 (26.7%) | |||||||||
| Neoplasm malignant | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Neoplasm progression | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Tumour haemorrhage | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Depressed level of consciousness | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Neuralgia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Paraparesis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Syncope | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Urinary tract obstruction | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Dyspnoea | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Interstitial lung disease | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Pleural effusion | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Pleurisy | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pleuritic pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pneumonitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pulmonary embolism | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Vascular disorders | ||||||||||||||||||
| Venous thrombosis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.6MG/KG Q3W | BMS-986148 1.2MG/KG Q3W | BMS-986148 0.4MG/KG QW | BMS-986148 0.6MG/KG QW | BMS-986148 0.8MG/KG Q3W+Nivolumab | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/2 (50%) | 2/2 (100%) | 3/3 (100%) | 8/8 (100%) | 10/10 (100%) | 57/59 (96.6%) | 8/8 (100%) | 4/4 (100%) | 27/30 (90%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 5/59 (8.5%) | 2/8 (25%) | 1/4 (25%) | 2/30 (6.7%) | |||||||||
| Lymphopenia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Thrombocytopenia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Atrial fibrillation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Mitral valve incompetence | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pericarditis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Sinus bradycardia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Tachycardia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Endocrine disorders | ||||||||||||||||||
| Hypothyroidism | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Eye disorders | ||||||||||||||||||
| Blepharitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Cataract | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 3/59 (5.1%) | 0/8 (0%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Chalazion | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Dry eye | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 2/8 (25%) | 0/10 (0%) | 5/59 (8.5%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Eye pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Lacrimation increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Narrow anterior chamber angle | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Strabismus | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Swelling of eyelid | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Vision blurred | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 6/59 (10.2%) | 0/8 (0%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Visual impairment | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Vitreous floaters | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal discomfort | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Abdominal distension | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 3/8 (37.5%) | 1/10 (10%) | 4/59 (6.8%) | 1/8 (12.5%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Abdominal pain | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 3/8 (37.5%) | 3/10 (30%) | 15/59 (25.4%) | 4/8 (50%) | 1/4 (25%) | 5/30 (16.7%) | |||||||||
| Abdominal pain lower | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 4/30 (13.3%) | |||||||||
| Abdominal pain upper | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 4/59 (6.8%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Ascites | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 3/10 (30%) | 5/59 (8.5%) | 0/8 (0%) | 0/4 (0%) | 6/30 (20%) | |||||||||
| Breath odour | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Constipation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 4/10 (40%) | 16/59 (27.1%) | 3/8 (37.5%) | 1/4 (25%) | 10/30 (33.3%) | |||||||||
| Diarrhoea | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 3/8 (37.5%) | 8/10 (80%) | 13/59 (22%) | 1/8 (12.5%) | 1/4 (25%) | 5/30 (16.7%) | |||||||||
| Dry mouth | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 3/10 (30%) | 5/59 (8.5%) | 1/8 (12.5%) | 0/4 (0%) | 5/30 (16.7%) | |||||||||
| Dyspepsia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 3/8 (37.5%) | 1/10 (10%) | 5/59 (8.5%) | 0/8 (0%) | 1/4 (25%) | 3/30 (10%) | |||||||||
| Dysphagia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 1/8 (12.5%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Eructation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Flatulence | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Gastrooesophageal reflux disease | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 3/59 (5.1%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Haemorrhoids | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Impaired gastric emptying | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Nausea | 1/2 (50%) | 1/2 (50%) | 3/3 (100%) | 5/8 (62.5%) | 7/10 (70%) | 30/59 (50.8%) | 3/8 (37.5%) | 1/4 (25%) | 13/30 (43.3%) | |||||||||
| Rectal haemorrhage | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Retching | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Stomatitis | 1/2 (50%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 3/10 (30%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Swollen tongue | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Umbilical hernia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Vomiting | 0/2 (0%) | 1/2 (50%) | 2/3 (66.7%) | 4/8 (50%) | 4/10 (40%) | 17/59 (28.8%) | 0/8 (0%) | 1/4 (25%) | 9/30 (30%) | |||||||||
| General disorders | ||||||||||||||||||
| Asthenia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Chest discomfort | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Chest pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 10/59 (16.9%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Chills | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Early satiety | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Fatigue | 0/2 (0%) | 1/2 (50%) | 1/3 (33.3%) | 5/8 (62.5%) | 8/10 (80%) | 32/59 (54.2%) | 3/8 (37.5%) | 3/4 (75%) | 15/30 (50%) | |||||||||
| Influenza like illness | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 1/4 (25%) | 2/30 (6.7%) | |||||||||
| Malaise | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 1/8 (12.5%) | 2/4 (50%) | 1/30 (3.3%) | |||||||||
| Mucosal inflammation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Non-cardiac chest pain | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 1/10 (10%) | 5/59 (8.5%) | 3/8 (37.5%) | 1/4 (25%) | 5/30 (16.7%) | |||||||||
| Oedema peripheral | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 2/10 (20%) | 8/59 (13.6%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Pain | 1/2 (50%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Pyrexia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 3/10 (30%) | 14/59 (23.7%) | 1/8 (12.5%) | 2/4 (50%) | 3/30 (10%) | |||||||||
| Hepatobiliary disorders | ||||||||||||||||||
| Hyperbilirubinaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Immune system disorders | ||||||||||||||||||
| Hypersensitivity | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Conjunctivitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Cystitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Lower respiratory tract infection | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Nasopharyngitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Oral herpes | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Pneumonia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 3/59 (5.1%) | 1/8 (12.5%) | 0/4 (0%) | 4/30 (13.3%) | |||||||||
| Respiratory tract infection | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Upper respiratory tract infection | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 4/30 (13.3%) | |||||||||
| Urinary tract infection | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 3/59 (5.1%) | 0/8 (0%) | 1/4 (25%) | 2/30 (6.7%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Fall | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Head injury | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Investigations | ||||||||||||||||||
| Alanine aminotransferase increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 2/8 (25%) | 6/10 (60%) | 33/59 (55.9%) | 3/8 (37.5%) | 3/4 (75%) | 10/30 (33.3%) | |||||||||
| Aspartate aminotransferase increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 3/8 (37.5%) | 5/10 (50%) | 35/59 (59.3%) | 2/8 (25%) | 3/4 (75%) | 12/30 (40%) | |||||||||
| Blood alkaline phosphatase increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 5/10 (50%) | 18/59 (30.5%) | 2/8 (25%) | 2/4 (50%) | 5/30 (16.7%) | |||||||||
| Blood bilirubin increased | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 1/8 (12.5%) | 2/10 (20%) | 8/59 (13.6%) | 2/8 (25%) | 2/4 (50%) | 2/30 (6.7%) | |||||||||
| Blood creatinine increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 1/8 (12.5%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Blood sodium increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Electrocardiogram QT prolonged | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Gamma-glutamyltransferase increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 4/59 (6.8%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Liver function test increased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Lymphocyte count decreased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Platelet count decreased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 3/59 (5.1%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Weight decreased | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 3/8 (37.5%) | 0/10 (0%) | 4/59 (6.8%) | 0/8 (0%) | 0/4 (0%) | 5/30 (16.7%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Decreased appetite | 0/2 (0%) | 1/2 (50%) | 1/3 (33.3%) | 6/8 (75%) | 5/10 (50%) | 26/59 (44.1%) | 2/8 (25%) | 2/4 (50%) | 11/30 (36.7%) | |||||||||
| Dehydration | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Hyperglycaemia | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 2/8 (25%) | 1/4 (25%) | 2/30 (6.7%) | |||||||||
| Hyperuricaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Hypoalbuminaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 4/59 (6.8%) | 0/8 (0%) | 0/4 (0%) | 4/30 (13.3%) | |||||||||
| Hypoglycaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Hypokalaemia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 5/59 (8.5%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Hypomagnesaemia | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 3/8 (37.5%) | 0/10 (0%) | 4/59 (6.8%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Hyponatraemia | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Hypophosphataemia | 1/2 (50%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 2/10 (20%) | 4/59 (6.8%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Increased appetite | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Arthralgia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 4/30 (13.3%) | |||||||||
| Back pain | 1/2 (50%) | 1/2 (50%) | 0/3 (0%) | 2/8 (25%) | 1/10 (10%) | 10/59 (16.9%) | 1/8 (12.5%) | 1/4 (25%) | 2/30 (6.7%) | |||||||||
| Flank pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 3/59 (5.1%) | 2/8 (25%) | 1/4 (25%) | 3/30 (10%) | |||||||||
| Groin pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Muscle spasms | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 3/10 (30%) | 5/59 (8.5%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Muscular weakness | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Musculoskeletal chest pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 4/59 (6.8%) | 0/8 (0%) | 1/4 (25%) | 4/30 (13.3%) | |||||||||
| Musculoskeletal discomfort | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Musculoskeletal pain | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 0/8 (0%) | 2/10 (20%) | 7/59 (11.9%) | 1/8 (12.5%) | 2/4 (50%) | 3/30 (10%) | |||||||||
| Myalgia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 3/59 (5.1%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Neck pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 3/59 (5.1%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Pain in extremity | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 4/59 (6.8%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Tumour pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Dizziness | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 2/8 (25%) | 3/10 (30%) | 5/59 (8.5%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Dysarthria | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Dysgeusia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 6/59 (10.2%) | 1/8 (12.5%) | 2/4 (50%) | 4/30 (13.3%) | |||||||||
| Headache | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 3/10 (30%) | 6/59 (10.2%) | 0/8 (0%) | 1/4 (25%) | 4/30 (13.3%) | |||||||||
| Horner's syndrome | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Neuropathy peripheral | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 4/59 (6.8%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Peripheral sensory neuropathy | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 3/59 (5.1%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Seizure | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Somnolence | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Psychiatric disorders | ||||||||||||||||||
| Abnormal dreams | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Anxiety | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 3/59 (5.1%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Confusional state | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 2/59 (3.4%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Delirium | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Depression | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Hallucination | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Hallucination, auditory | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Insomnia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 2/8 (25%) | 0/10 (0%) | 4/59 (6.8%) | 1/8 (12.5%) | 0/4 (0%) | 6/30 (20%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Acute kidney injury | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Chromaturia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Nocturia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Proteinuria | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Urinary retention | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Urine odour abnormal | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Reproductive system and breast disorders | ||||||||||||||||||
| Pelvic pain | 0/2 (0%) | 1/2 (50%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Testicular pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 3/8 (37.5%) | 2/10 (20%) | 13/59 (22%) | 0/8 (0%) | 0/4 (0%) | 5/30 (16.7%) | |||||||||
| Dysphonia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 1/8 (12.5%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Dyspnoea | 1/2 (50%) | 1/2 (50%) | 0/3 (0%) | 1/8 (12.5%) | 5/10 (50%) | 19/59 (32.2%) | 1/8 (12.5%) | 1/4 (25%) | 5/30 (16.7%) | |||||||||
| Dyspnoea exertional | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Epistaxis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 3/59 (5.1%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Haemoptysis | 1/2 (50%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Hiccups | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 2/10 (20%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Hypoxia | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Nasal congestion | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Oropharyngeal pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Pleural effusion | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 4/59 (6.8%) | 2/8 (25%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Pleuritic pain | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 3/10 (30%) | 7/59 (11.9%) | 2/8 (25%) | 1/4 (25%) | 3/30 (10%) | |||||||||
| Productive cough | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 7/59 (11.9%) | 1/8 (12.5%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Rales | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Throat irritation | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 1/30 (3.3%) | |||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Dry skin | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 1/10 (10%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Night sweats | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 2/10 (20%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Pruritus | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 1/10 (10%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 6/30 (20%) | |||||||||
| Rash | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 4/59 (6.8%) | 0/8 (0%) | 1/4 (25%) | 4/30 (13.3%) | |||||||||
| Rash macular | 0/2 (0%) | 0/2 (0%) | 1/3 (33.3%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 1/30 (3.3%) | |||||||||
| Rash papular | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 0/4 (0%) | 3/30 (10%) | |||||||||
| Skin odour abnormal | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 0/8 (0%) | 1/4 (25%) | 0/30 (0%) | |||||||||
| Vascular disorders | ||||||||||||||||||
| Flushing | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 0/10 (0%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Hypertension | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 2/59 (3.4%) | 0/8 (0%) | 0/4 (0%) | 2/30 (6.7%) | |||||||||
| Hypotension | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 1/8 (12.5%) | 2/10 (20%) | 1/59 (1.7%) | 0/8 (0%) | 0/4 (0%) | 0/30 (0%) | |||||||||
| Systolic hypertension | 0/2 (0%) | 0/2 (0%) | 0/3 (0%) | 0/8 (0%) | 0/10 (0%) | 0/59 (0%) | 1/8 (12.5%) | 0/4 (0%) | 0/30 (0%) | |||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title | Bristol-Myers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | Please Email: |
| Clinical.Trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02341625
Other Study ID Numbers:
- CA008-002
- 2014-002485-70
First Posted:
Jan 19, 2015
Last Update Posted:
Aug 18, 2022
Last Verified:
Jul 1, 2022