An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03363776
• Collaborator: (none)
• Enrollment: 10
• Locations: 3
• Arms: 3
• Actual Duration (Months): 23.5
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Biological: BMS-986277; Biological: Nivolumab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
• Actual Study Start Date: Dec 6, 2017
• Actual Primary Completion Date: Nov 22, 2019
• Actual Study Completion Date: Nov 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monotherapy BMS-986277 administered alone	Biological: BMS-986277; Specified dose on specified days
Experimental: Combination Dose Escalation Therapy BMS-986277 administered in combination with Nivolumab	Biological: BMS-986277; Specified dose on specified days; Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo BMS-963558
Experimental: Combination Expansion Therapy BMS-986277 monotherapy with option for subsequent Nivolumab therapy	Biological: BMS-986277; Specified dose on specified days; Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo BMS-963558

Outcome Measures

Primary Outcome Measures

1. Number of Participants With an Adverse Event (AE) [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced an AE during the course of the study.

2. Number of Participants With a Serious Adverse Event (SAE) [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced a SAE during the course of the study.

3. Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.

4. Number of Participants With an Adverse Event (AE) Leading to Discontinuation [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced an AE leading to discontinuation during the course of the study.

5. Number of Participants With an Adverse Event (AE) Leading to Death [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced an AE leading to death during the course of the study.

6. Number of Participants With a Clinical Laboratory Test Abnormality [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced a clinical laboratory test abnormality during the course of the study.

7. Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers [from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)]

   Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.

Secondary Outcome Measures

1. Objective Response Rate (ORR) [at Weeks 8, 16 and 24]

   ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data. Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method

2. Disease Control Rate (DCR) [at Weeks 8, 16 and 24]

   DCR includes complete response (CR), partial response (PR), and stable disease (SD). Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method

3. Median Duration of Response (mDOR) [at Weeks 8, 16 and 24]

   DOR for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1/PCWG3 or death, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation)

4. Median Progression-Free Survival (mPFS) [at Weeks 8, 16 and 24, to progression]

   PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.

5. Progression-Free Survival Rate (PFSR) [at Weeks 8, 16 and 24]

   PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.

6. Cmax [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

   Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax is defined as the maximum observed blood concentration.

7. Tmax [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

   Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Tmax is defined as the time of maximum observed blood concentration.

8. AUC(0-T) [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

   Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration.

9. AUC(INF) [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

   Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time.

10. T-HALF [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALF is defined as the apparent terminal half-life.

11. CLT [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. CLT is defined as the total body clearance.

12. Vss [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vss is defined as the volume of distribution at steady-state.

13. Vz [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vz is defined as the volume of distribution of the elimination phase.

14. AUC(0-48) [Cycle 1 (from time zero to 48 hours postdose)]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose

15. AUC(0-8) [Cycle 1 (from time zero to 8 hours postdose)]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose

16. C48 [Cycle 1 at 48 hours postdose]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. C48 is defined as the blood concentration at 48 hours postdose.

17. Css-avg [Cycle 1 (from time zero to 48 hours postdose)]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC[0-48]/48).

18. AI_AUC [Cycle 1 (Day 19, Day 15)]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy.

19. AI_Cmax [Cycle 1 (Day 19, Day 15)]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy.

20. T-HALFeff [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax)

21. Ctrough [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Ctrough is defined as the trough observed blood concentration.

22. Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response [Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits]

    Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3

• Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion

• Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment

• ECOG performance status less than or equal to 2

Exclusion Criteria:

• Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease

• Participants with carcinomatous meningitis

• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment

• Participants with active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanford Research	Sioux Falls	South Dakota	United States	57104
2	Local Institution	Ottawa	Ontario	Canada	K1H 8L6
3	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 1Z5

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol - Aug 15, 2018
• Statistical Analysis Plan - Mar 12, 2018

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03363776
• Other Study ID Numbers: CA034-001; 2017-002199-24
• First Posted: Dec 6, 2017
• Last Update Posted: Dec 19, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nivolumab

Study Results

Participant Flow

Pre-assignment Detail	10 participants randomized and treated

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Period Title: Overall Study
STARTED	4	3	3
COMPLETED	1	0	1
NOT COMPLETED	3	3	2

Baseline Characteristics

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)	Total
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	Total of all reporting groups
Overall Participants	4	3	3	10
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61 (2.4)	59 (10.4)	47 (12.1)	57 (9.9)
Age, Customized (Count of Participants)
> 65 years	0 0%	1 33.3%	0 0%	1 10%
<= 65 years	4 100%	2 66.7%	3 100%	9 90%
Sex: Female, Male (Count of Participants)
Female	2 50%	1 33.3%	2 66.7%	5 50%
Male	2 50%	2 66.7%	1 33.3%	5 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	1 25%	0 0%	1 33.3%	2 20%
Unknown or Not Reported	3 75%	3 100%	2 66.7%	8 80%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	4 100%	3 100%	3 100%	10 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an Adverse Event (AE)
Description	Number of participants who experienced an AE during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

2. Primary Outcome

Title	Number of Participants With a Serious Adverse Event (SAE)
Description	Number of participants who experienced a SAE during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

3. Primary Outcome

Title	Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
Description	Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

4. Primary Outcome

Title	Number of Participants With an Adverse Event (AE) Leading to Discontinuation
Description	Number of participants who experienced an AE leading to discontinuation during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

5. Primary Outcome

Title	Number of Participants With an Adverse Event (AE) Leading to Death
Description	Number of participants who experienced an AE leading to death during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

6. Primary Outcome

Title	Number of Participants With a Clinical Laboratory Test Abnormality
Description	Number of participants who experienced a clinical laboratory test abnormality during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

7. Primary Outcome

Title	Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
Description	Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.
Time Frame	from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

8. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data. Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
Time Frame	at Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Percentage of Participants]	NA NaN	NA NaN	NA NaN

9. Secondary Outcome

Title	Disease Control Rate (DCR)
Description	DCR includes complete response (CR), partial response (PR), and stable disease (SD). Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
Time Frame	at Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Percentage of Participants]	NA NaN	NA NaN	NA NaN

10. Secondary Outcome

Title	Median Duration of Response (mDOR)
Description	DOR for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1/PCWG3 or death, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation)
Time Frame	at Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

11. Secondary Outcome

Title	Median Progression-Free Survival (mPFS)
Description	PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
Time Frame	at Weeks 8, 16 and 24, to progression

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of Participants]	NA NaN	NA NaN	NA NaN

12. Secondary Outcome

Title	Progression-Free Survival Rate (PFSR)
Description	PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
Time Frame	at Weeks 8, 16 and 24

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Percentage of Participants]	NA NaN	NA NaN	NA NaN

13. Secondary Outcome

Title	Cmax
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax is defined as the maximum observed blood concentration.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	NA (NA)	NA (NA)	NA (NA)

14. Secondary Outcome

Title	Tmax
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Tmax is defined as the time of maximum observed blood concentration.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Median (Full Range) [hour]	NA	NA	NA

15. Secondary Outcome

Title	AUC(0-T)
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL]	NA (NA)	NA (NA)	NA (NA)

16. Secondary Outcome

Title	AUC(INF)
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL]	NA (NA)	NA (NA)	NA (NA)

17. Secondary Outcome

Title	T-HALF
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALF is defined as the apparent terminal half-life.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Mean (Standard Deviation) [hour]	NA (NA)	NA (NA)	NA (NA)

18. Secondary Outcome

Title	CLT
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. CLT is defined as the total body clearance.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [liter]	NA (NA)	NA (NA)	NA (NA)

19. Secondary Outcome

Title	Vss
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vss is defined as the volume of distribution at steady-state.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [liter]	NA (NA)	NA (NA)	NA (NA)

20. Secondary Outcome

Title	Vz
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vz is defined as the volume of distribution of the elimination phase.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [liter]	NA (NA)	NA (NA)	NA (NA)

21. Secondary Outcome

Title	AUC(0-48)
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose
Time Frame	Cycle 1 (from time zero to 48 hours postdose)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL]	NA (NA)	NA (NA)	NA (NA)

22. Secondary Outcome

Title	AUC(0-8)
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose
Time Frame	Cycle 1 (from time zero to 8 hours postdose)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL]	NA (NA)	NA (NA)	NA (NA)

23. Secondary Outcome

Title	C48
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. C48 is defined as the blood concentration at 48 hours postdose.
Time Frame	Cycle 1 at 48 hours postdose

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	NA (NA)	NA (NA)	NA (NA)

24. Secondary Outcome

Title	Css-avg
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC[0-48]/48).
Time Frame	Cycle 1 (from time zero to 48 hours postdose)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	NA (NA)	NA (NA)	NA (NA)

25. Secondary Outcome

Title	AI_AUC
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy.
Time Frame	Cycle 1 (Day 19, Day 15)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [ratio AUC(0-48),C1D19 to AUC(0-48),C1D15]	NA (NA)	NA (NA)	NA (NA)

26. Secondary Outcome

Title	AI_Cmax
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy.
Time Frame	Cycle 1 (Day 19, Day 15)

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [ratio of Cmax,C1D19 to Cmax,C1D15]	NA (NA)	NA (NA)	NA (NA)

27. Secondary Outcome

Title	T-HALFeff
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax)
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Median (Full Range) [hour]	NA	NA	NA

28. Secondary Outcome

Title	Ctrough
Description	Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Ctrough is defined as the trough observed blood concentration.
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	NA (NA)	NA (NA)	NA (NA)

29. Secondary Outcome

Title	Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
Description	Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
Time Frame	Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits

Outcome Measure Data

Analysis Population Description

All treated participants Study terminated, data not reported due to privacy reasons

Arm/Group Title	Arm A (Part 1)	Arm B (Part 1)	Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.	BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
Measure Participants	4	3	3
Number [Number of participants]	NA NaN	NA NaN	NA NaN

Adverse Events

Time Frame	AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
Arm/Group Title	Arm A (Part 1)		Arm B (Part 1)		Arm C (Part 1)
Arm/Group Description	BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.		BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.		BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
All Cause Mortality
	Arm A (Part 1)		Arm B (Part 1)		Arm C (Part 1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/4 (50%)		2/3 (66.7%)		2/3 (66.7%)
Serious Adverse Events
	Arm A (Part 1)		Arm B (Part 1)		Arm C (Part 1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		0/3 (0%)		2/3 (66.7%)
Gastrointestinal disorders
Ascites	1/4 (25%)		0/3 (0%)		0/3 (0%)
Immune system disorders
Cytokine release syndrome	0/4 (0%)		0/3 (0%)		1/3 (33.3%)
Metabolism and nutrition disorders
Dehydration	0/4 (0%)		0/3 (0%)		1/3 (33.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	1/4 (25%)		0/3 (0%)		2/3 (66.7%)
Other (Not Including Serious) Adverse Events
	Arm A (Part 1)		Arm B (Part 1)		Arm C (Part 1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		3/3 (100%)		3/3 (100%)
Gastrointestinal disorders
Abdominal distension	1/4 (25%)		0/3 (0%)		0/3 (0%)
Abdominal pain	1/4 (25%)		1/3 (33.3%)		0/3 (0%)
Abdominal pain lower	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Constipation	1/4 (25%)		0/3 (0%)		0/3 (0%)
Diarrhoea	2/4 (50%)		0/3 (0%)		0/3 (0%)
Dry mouth	0/4 (0%)		0/3 (0%)		1/3 (33.3%)
Gastrooesophageal reflux disease	1/4 (25%)		1/3 (33.3%)		0/3 (0%)
Haemorrhoidal haemorrhage	1/4 (25%)		0/3 (0%)		0/3 (0%)
Lip ulceration	1/4 (25%)		0/3 (0%)		0/3 (0%)
Nausea	3/4 (75%)		1/3 (33.3%)		2/3 (66.7%)
Stomatitis	0/4 (0%)		0/3 (0%)		1/3 (33.3%)
Vomiting	1/4 (25%)		1/3 (33.3%)		2/3 (66.7%)
General disorders
Chills	1/4 (25%)		1/3 (33.3%)		2/3 (66.7%)
Fatigue	2/4 (50%)		1/3 (33.3%)		3/3 (100%)
Influenza like illness	0/4 (0%)		2/3 (66.7%)		0/3 (0%)
Oedema peripheral	0/4 (0%)		0/3 (0%)		1/3 (33.3%)
Pyrexia	0/4 (0%)		0/3 (0%)		3/3 (100%)
Immune system disorders
Cytokine release syndrome	0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)
Infections and infestations
Urinary tract infection	1/4 (25%)		0/3 (0%)		0/3 (0%)
Investigations
Alanine aminotransferase increased	1/4 (25%)		0/3 (0%)		0/3 (0%)
Amylase increased	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Aspartate aminotransferase increased	1/4 (25%)		1/3 (33.3%)		0/3 (0%)
Blood bilirubin increased	1/4 (25%)		0/3 (0%)		0/3 (0%)
Blood creatinine increased	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Lipase increased	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/4 (50%)		1/3 (33.3%)		0/3 (0%)
Hypomagnesaemia	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Hypophosphataemia	0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/4 (25%)		1/3 (33.3%)		0/3 (0%)
Back pain	0/4 (0%)		1/3 (33.3%)		2/3 (66.7%)
Muscle spasms	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Myalgia	0/4 (0%)		1/3 (33.3%)		1/3 (33.3%)
Neck pain	1/4 (25%)		0/3 (0%)		0/3 (0%)
Nervous system disorders
Headache	1/4 (25%)		2/3 (66.7%)		1/3 (33.3%)
Sciatica	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Psychiatric disorders
Insomnia	1/4 (25%)		0/3 (0%)		0/3 (0%)
Renal and urinary disorders
Hypertonic bladder	1/4 (25%)		0/3 (0%)		0/3 (0%)
Micturition urgency	1/4 (25%)		0/3 (0%)		0/3 (0%)
Reproductive system and breast disorders
Haematospermia	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/4 (25%)		1/3 (33.3%)		0/3 (0%)
Dyspnoea	1/4 (25%)		0/3 (0%)		0/3 (0%)
Oropharyngeal pain	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Productive cough	0/4 (0%)		1/3 (33.3%)		0/3 (0%)
Vascular disorders
Hot flush	0/4 (0%)		0/3 (0%)		1/3 (33.3%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.