A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)
Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02859324
Collaborator
(none)
21
14
1
42.2
1.5
0
Study Details
Study Description
Brief Summary
CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Study population included subjects who had progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
The dose escalation part of the study was designed to explore three dose levels of CC-122 to identify the recommended phase 2 dose (RP2D) to be used in the expansion phase. Approximately 20 subjects were to be enrolled in the dose escalation part of the study. Subjects could be treated for up to 2 years, or until progression of disease, unacceptable toxicity, subject/physician decision, withdrawal of consent, death. Safety follow up until 28 days after CC122 treatment and 90 days after nivolumab treatment. RECIST 1.1 criteria was used to determine response. Survival follow up until death, withdrawal of consent, or the study closes. Subjects were permitted to continue treatment beyond progression (TBP) if they continue to meet protocol criteria, had stable performance status, had clinical benefit, other treatment options were discussed. A separate ICF was signed to continue TBP.
During the dose escalation phase, CC-122 was administered orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle. Once the RP2D for dosing of CC-122 in combination with nivolumab was defined, expansion (Phase 2) would start. A modified 3+3 dose escalation design was used to identify the initial toxicity of the combination. Up to six subjects were concurrently enrolled into a dose level. Decisions as to which dose level to enroll a new subject were based on the number of subjects enrolled and evaluable, the number of subjects experiencing DLTs, and the number of subjects enrolled but who are not yet evaluable for toxicity in the current cohort at the time of new subject entry. A Safety Review Committee (SRC) comprised of investigators participating in the study made dose escalation decisions based on these criteria.
After completion of the Dose Escalation Phase, the Dose Expansion Phase of the study did not proceed due to the changing landscape in the treatment of HCC. There were no additional safety concerns or safety signals identified in the dose escalation phase of the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, MultiCenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability and Preliminary Efficacy of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellullar Carcinoma (HCC) Following First Line Treatment Failure
Actual Study Start Date
:
Sep 20, 2016
Actual Primary Completion Date
:
Mar 27, 2020
Actual Study Completion Date
:
Mar 27, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CC-122 with Nivolumab CC-122 orally 5/7 days with nivolumab Intravenously (IV) 3mg/kg every 2 weeks. Cohorts of up to 6 subjects per dose level until Recommended Phase 2 dose (RP2D). |
Drug: CC-122
Drug: Nivolumab
|
Outcome Measures
Primary Outcome Measures
- Incidence of Dose Limiting Toxicities (DLTs) [28 days]
During dose escalation, the DLT assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. A DLT is defined as any of the following toxicities occurring within the DLT assessment window unless the event can clearly be determined to be unrelated to the drug.
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) [From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years)]
During dose escalation, the TEAE phase 1 assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. Number of participants who experienced a TEAE during the course of the study.
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [up to 2 years]
ORR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).
Secondary Outcome Measures
- Disease Control Rate (DCR) by RECIST 1.1 [up to 2 years]
DCR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) or stable disease (SD).
- Duration of Response (DoR) by RECIST 1.1 [up to 2 years]
Duration of response is measured from the date the criterion is first met for CR/PR using RECIST 1.1 rules (whichever is first recorded) until the first date when progressive disease using RECIST 1.1 is documented or death occurred.
- Progression-Free Survival (PFS) by RECIST 1.1 [up to 2 years]
Progression-Free Survival (PFS) is defined as the time from the first dose date of study drug until tumor progression or death, whichever occurs first. A subject who has neither progressed nor died or who progresses or dies after an extended lost-to-follow up time (two or more missed assessments) is censored on the date of last adequate tumor assessment. Subjects without valid baseline or post-baseline tumor assessments are censored on their first dose date. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data.
- Overall Survival (OS) by RECIST 1.1 [up to 2 years]
Overall Survival (OS) is measured as the time from the first dose of study drug to death from any cause. Participants who have no death reported are censored at the last contact date the participant is known to be alive. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data.
- Time to Progression (TTP) by RECIST 1.1 [up to 2 years]
Time to Progression (TTP) is defined as the time from the first dose date of study drug until tumor progression; TTP does not include death. The censoring rules are the same as PFS except that deaths without progression are censored at last adequate tumor assessment. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data.
- Maximum Observed Concentration (Cmax) [28 days]
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
- Area Under the Concentration Time Curve (AUC) [28 days]
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
- Time to Maximum Concentration (Tmax) [28 days]
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
- Terminal Half-life (T-HALF) [28 days]
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
- Apparent Volume of Distribution (Vz/F) [28 days]
Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects must satisfy the following criteria to be enrolled in the study:
-
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
-
Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) Guidelines.
-
Subjects who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
-
Subject has at least one measurable lesion according to RECIST 1.1.
-
Subject has a life expectancy of ≥ 12 weeks
-
Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
-
Subject has adequate hematologic function and adequate hepatic function at screening
Exclusion Criteria:
-
The presence of any of the following will exclude a subject from enrollment:
-
Subject has received more than 2 previous systemic therapies for Hepatocellular carcinoma (HCC).
-
Subject has received previous treatment with any anti-PD-1 (Programmed death 1) or anti-PD-L1 (PD-1 ligand receptor) antibody
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Division of Hematology Oncology | Los Angeles | California | United States | 90095-1752 |
| 2 | University of Florida | Gainesville | Florida | United States | 32610 |
| 3 | NYU Langone Medical Center | New York | New York | United States | 10016 |
| 4 | Mary Crowley Cancer Research | Dallas | Texas | United States | 75251 |
| 5 | Institut Paoli Calmettes | Marseille Cedex 9 | France | 13273 | |
| 6 | Centre Eugene Marquis | Rennes | France | 35200 | |
| 7 | Institut Universitaire du Cancer IUCT - Oncopole | Toulouse Cedex | France | 31059 | |
| 8 | Institut Gustave Roussy Hematologie | Villejuif CEDEX | France | 94805 | |
| 9 | IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center | Milan | Italy | 20089 | |
| 10 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | |
| 11 | Istituto Nazionale Tumori Regina Elena | Roma | Italy | 144 | |
| 12 | Hospital Universitario Vall D Hebron | Barcelona | Spain | 8035 | |
| 13 | Hospital Ramon y Cajal | Madrid | Spain | 28034 | |
| 14 | Hospital 12 de Octubre | Madrid | Spain | 28041 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Akshay Patel, Celgene Corporation
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT02859324
Other Study ID Numbers:
- CC-122-HCC-002
- 2016-000112-15
First Posted:
Aug 9, 2016
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021
Keywords provided by Celgene
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 21 participants treated |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Period Title: Overall Study | |||
| STARTED | 7 | 9 | 5 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 7 | 9 | 5 |
Baseline Characteristics
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab | Total |
|---|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | Total of all reporting groups |
| Overall Participants | 7 | 9 | 5 | 21 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
63.9
(10.32)
|
60.4
(11.75)
|
66.4
(10.06)
|
63.0
(10.65)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
1
11.1%
|
1
20%
|
2
9.5%
|
| Male |
7
100%
|
8
88.9%
|
4
80%
|
19
90.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
4
57.1%
|
3
33.3%
|
5
100%
|
12
57.1%
|
| Unknown or Not Reported |
3
42.9%
|
6
66.7%
|
0
0%
|
9
42.9%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Black or African American |
0
0%
|
1
11.1%
|
0
0%
|
1
4.8%
|
| White |
4
57.1%
|
2
22.2%
|
5
100%
|
11
52.4%
|
| Not collected or reported |
3
42.9%
|
6
66.7%
|
0
0%
|
9
42.9%
|
Outcome Measures
| Title | Incidence of Dose Limiting Toxicities (DLTs) |
|---|---|
| Description | During dose escalation, the DLT assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. A DLT is defined as any of the following toxicities occurring within the DLT assessment window unless the event can clearly be determined to be unrelated to the drug. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Count of Participants [Participants] |
1
14.3%
|
1
11.1%
|
2
40%
|
| Title | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | During dose escalation, the TEAE phase 1 assessment period is defined as Days 1 to 28 of Cycle 1 including the predose assessments specified for Day 1 of Cycle 2. Number of participants who experienced a TEAE during the course of the study. |
| Time Frame | From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| TEAEs |
7
100%
|
9
100%
|
5
100%
|
| Participants with Grade 3-4 TEAEs |
7
100%
|
6
66.7%
|
4
80%
|
| Participants with Grade 5 TEAEs |
2
28.6%
|
0
0%
|
3
60%
|
| Participants with serious TEAEs |
6
85.7%
|
5
55.6%
|
4
80%
|
| Participants with TEAE leading to discontinuation of CC-122 |
2
28.6%
|
1
11.1%
|
3
60%
|
| Participants with TEAE leading to discontinuation of nivolumab |
1
14.3%
|
1
11.1%
|
3
60%
|
| Participants with TEAE leading to discontinuation of both study drugs |
1
14.3%
|
1
11.1%
|
2
40%
|
| Title | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
|---|---|
| Description | ORR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). |
| Time Frame | up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Number (95% Confidence Interval) [Percentage of participants] |
42.9
612.9%
|
0
0%
|
0
0%
|
| Title | Disease Control Rate (DCR) by RECIST 1.1 |
|---|---|
| Description | DCR is is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) or stable disease (SD). |
| Time Frame | up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Number (95% Confidence Interval) [Percentage of participants] |
71.4
1020%
|
44.4
493.3%
|
80.0
1600%
|
| Title | Duration of Response (DoR) by RECIST 1.1 |
|---|---|
| Description | Duration of response is measured from the date the criterion is first met for CR/PR using RECIST 1.1 rules (whichever is first recorded) until the first date when progressive disease using RECIST 1.1 is documented or death occurred. |
| Time Frame | up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Median (95% Confidence Interval) [Days] |
NA
|
NA
|
NA
|
| Title | Progression-Free Survival (PFS) by RECIST 1.1 |
|---|---|
| Description | Progression-Free Survival (PFS) is defined as the time from the first dose date of study drug until tumor progression or death, whichever occurs first. A subject who has neither progressed nor died or who progresses or dies after an extended lost-to-follow up time (two or more missed assessments) is censored on the date of last adequate tumor assessment. Subjects without valid baseline or post-baseline tumor assessments are censored on their first dose date. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. |
| Time Frame | up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Median (95% Confidence Interval) [Days] |
130.0
|
95.0
|
122.0
|
| Title | Overall Survival (OS) by RECIST 1.1 |
|---|---|
| Description | Overall Survival (OS) is measured as the time from the first dose of study drug to death from any cause. Participants who have no death reported are censored at the last contact date the participant is known to be alive. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. |
| Time Frame | up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Median (95% Confidence Interval) [Days] |
320.0
|
303.0
|
135.0
|
| Title | Time to Progression (TTP) by RECIST 1.1 |
|---|---|
| Description | Time to Progression (TTP) is defined as the time from the first dose date of study drug until tumor progression; TTP does not include death. The censoring rules are the same as PFS except that deaths without progression are censored at last adequate tumor assessment. Median and the 2-sided 95% confidence interval (CI) are based on Kaplan-Meier estimate of progression-free survival and time to progression using both observed and censored data. |
| Time Frame | up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated participants |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 7 | 9 | 5 |
| Median (95% Confidence Interval) [Days] |
NA
|
95.0
|
166.0
|
| Title | Maximum Observed Concentration (Cmax) |
|---|---|
| Description | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 2 | 9 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
56.3
(48.4)
|
81.0
(32.8)
|
82.6
(NA)
|
| Title | Area Under the Concentration Time Curve (AUC) |
|---|---|
| Description | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 2 | 9 | 1 |
| Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL] |
235.3
(17.3)
|
399.8
(29.7)
|
257.9
(NA)
|
| Title | Time to Maximum Concentration (Tmax) |
|---|---|
| Description | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 2 | 9 | 1 |
| Median (Full Range) [hour] |
0.5
|
1.0
|
1.0
|
| Title | Terminal Half-life (T-HALF) |
|---|---|
| Description | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 2 | 8 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [hour] |
8.4
(61.4)
|
6.4
(42.1)
|
| Title | Apparent Volume of Distribution (Vz/F) |
|---|---|
| Description | Blood was collected according to intensive and sparse sampling strategies to estimate the population pharmacokinetic (PK) of CC-122 when administered in combination with nivolumab. |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) Evaluable Population -All participants who enrolled and received at least one dose of either investigational product (IP) and had at least one measurable concentration of CC-122 or nivolumab. Note: Nivolumab participants did not qualify for data analysis. |
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab |
|---|---|---|---|
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. |
| Measure Participants | 0 | 1 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [liter] |
40.1
(NA)
|
Adverse Events
| Time Frame | From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years) for all serious and non-serious adverse events. For all-cause mortality, the timeframe of reporting is over the entirety of the study (ca. 3.5 years). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab | |||
| Arm/Group Description | CC-122 2.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 3.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | CC-122 4.0 mg orally 5 consecutive days out of 7 (5 days on/2 days off weekly) on Days 1 to 5, 8 to 12, 15 to 19 and 22 to 26 of each 28-day cycle, and nivolumab 3.0 mg/kg intravenously (IV) every 2 weeks. | |||
All Cause Mortality |
||||||
| CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/7 (57.1%) | 6/9 (66.7%) | 5/5 (100%) | |||
Serious Adverse Events |
||||||
| CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/7 (85.7%) | 5/9 (55.6%) | 4/5 (80%) | |||
| Gastrointestinal disorders | ||||||
| Ascites | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Rectal haemorrhage | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| General disorders | ||||||
| Disease progression | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| General physical health deterioration | 1/7 (14.3%) | 0/9 (0%) | 2/5 (40%) | |||
| Hepatobiliary disorders | ||||||
| Jaundice cholestatic | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Infections and infestations | ||||||
| Abdominal wall abscess | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Herpes zoster | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Liver abscess | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Peritonitis bacterial | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Pulmonary sepsis | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Metabolism and nutrition disorders | ||||||
| Hyperglycaemia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Hyponatraemia | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Musculoskeletal chest pain | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tumour pain | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Nervous system disorders | ||||||
| Cerebrovascular accident | 0/7 (0%) | 1/9 (11.1%) | 1/5 (20%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Urinary retention | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Haemoptysis | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash maculo-papular | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| CC-122 2mg + Nivolumab | CC-122 3mg + Nivolumab | CC-122 4mg + Nivolumab | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/7 (100%) | 9/9 (100%) | 5/5 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/7 (14.3%) | 2/9 (22.2%) | 1/5 (20%) | |||
| Neutropenia | 2/7 (28.6%) | 5/9 (55.6%) | 1/5 (20%) | |||
| Thrombocytopenia | 3/7 (42.9%) | 2/9 (22.2%) | 0/5 (0%) | |||
| Cardiac disorders | ||||||
| Cardiac failure congestive | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Sinus bradycardia | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Tachycardia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Endocrine disorders | ||||||
| Hyperthyroidism | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Eye disorders | ||||||
| Eye pain | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Eyelid rash | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Lacrimation increased | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal distension | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Abdominal pain | 1/7 (14.3%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Abdominal pain upper | 3/7 (42.9%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Ascites | 2/7 (28.6%) | 1/9 (11.1%) | 2/5 (40%) | |||
| Constipation | 2/7 (28.6%) | 3/9 (33.3%) | 0/5 (0%) | |||
| Diarrhoea | 1/7 (14.3%) | 1/9 (11.1%) | 1/5 (20%) | |||
| Dry mouth | 1/7 (14.3%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Haematochezia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Nausea | 0/7 (0%) | 2/9 (22.2%) | 0/5 (0%) | |||
| Stomatitis | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Vomiting | 0/7 (0%) | 4/9 (44.4%) | 1/5 (20%) | |||
| General disorders | ||||||
| Asthenia | 4/7 (57.1%) | 1/9 (11.1%) | 1/5 (20%) | |||
| Chills | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Fatigue | 0/7 (0%) | 3/9 (33.3%) | 2/5 (40%) | |||
| General physical health deterioration | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Oedema peripheral | 1/7 (14.3%) | 4/9 (44.4%) | 2/5 (40%) | |||
| Pyrexia | 1/7 (14.3%) | 2/9 (22.2%) | 2/5 (40%) | |||
| Swelling | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic failure | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Hyperbilirubinaemia | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Jaundice | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Jaundice cholestatic | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Infections and infestations | ||||||
| Bronchitis | 2/7 (28.6%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Cellulitis | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Conjunctivitis | 2/7 (28.6%) | 0/9 (0%) | 0/5 (0%) | |||
| Escherichia urinary tract infection | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Gastroenteritis | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Nasopharyngitis | 2/7 (28.6%) | 0/9 (0%) | 0/5 (0%) | |||
| Pneumonia | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Rash pustular | 0/7 (0%) | 2/9 (22.2%) | 0/5 (0%) | |||
| Respiratory tract infection | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Tinea versicolour | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Urinary tract infection | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Infusion related reaction | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 1/7 (14.3%) | 1/9 (11.1%) | 3/5 (60%) | |||
| Amylase increased | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Aspartate aminotransferase increased | 1/7 (14.3%) | 1/9 (11.1%) | 4/5 (80%) | |||
| Blood alkaline phosphatase increased | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Blood bilirubin increased | 2/7 (28.6%) | 0/9 (0%) | 2/5 (40%) | |||
| Blood creatine increased | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Blood creatine phosphokinase increased | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Blood phosphorus decreased | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Electrocardiogram QT prolonged | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Gamma-glutamyltransferase increased | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Lipase increased | 2/7 (28.6%) | 0/9 (0%) | 0/5 (0%) | |||
| Neutrophil count decreased | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Troponin I increased | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Weight decreased | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Hyperkalaemia | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Hypoalbuminaemia | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Hypokalaemia | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Hypomagnesaemia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Hyponatraemia | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Back pain | 0/7 (0%) | 1/9 (11.1%) | 1/5 (20%) | |||
| Muscle spasms | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Musculoskeletal stiffness | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Neck pain | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Torticollis | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tumour pain | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Nervous system disorders | ||||||
| Aphasia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Encephalopathy | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Lacunar infarction | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Peripheral motor neuropathy | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Somnolence | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Psychiatric disorders | ||||||
| Anxiety disorder | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Confusional state | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Insomnia | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Urinary incontinence | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Erectile dysfunction | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 1/7 (14.3%) | 0/9 (0%) | 1/5 (20%) | |||
| Dyspnoea | 0/7 (0%) | 2/9 (22.2%) | 0/5 (0%) | |||
| Epistaxis | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Oropharyngeal pain | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dry skin | 1/7 (14.3%) | 2/9 (22.2%) | 0/5 (0%) | |||
| Erythema | 1/7 (14.3%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Exfoliative rash | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Hair colour changes | 1/7 (14.3%) | 0/9 (0%) | 0/5 (0%) | |||
| Palmar-plantar erythrodysaesthesia syndrome | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Pruritus | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Pruritus generalised | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
| Rash macular | 0/7 (0%) | 1/9 (11.1%) | 1/5 (20%) | |||
| Rash maculo-papular | 1/7 (14.3%) | 2/9 (22.2%) | 3/5 (60%) | |||
| Vascular disorders | ||||||
| Hypertension | 0/7 (0%) | 1/9 (11.1%) | 0/5 (0%) | |||
| Hypotension | 0/7 (0%) | 0/9 (0%) | 1/5 (20%) | |||
Limitations/Caveats
[Not Specified]
More Information
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.
Results Point of Contact
| Name/Title | Bristol-Myers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | Please email: |
| Clinical.Trials@bms.com |
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT02859324
Other Study ID Numbers:
- CC-122-HCC-002
- 2016-000112-15
First Posted:
Aug 9, 2016
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021