Trial Outcomes & Findings for A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC) (NCT NCT02859324)
NCT ID: NCT02859324
Last Updated: 2021-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
28 days
Results posted on
2021-05-11
Participant Flow
21 participants treated
Participant milestones
| Measure |
CC-122 2mg + Nivolumab
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 3mg + Nivolumab
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 4mg + Nivolumab
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
5
|
Reasons for withdrawal
| Measure |
CC-122 2mg + Nivolumab
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 3mg + Nivolumab
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 4mg + Nivolumab
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.
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
6
|
5
|
|
Overall Study
Other reasons
|
3
|
3
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)
Baseline characteristics by cohort
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
66.4 Years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 10.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not collected or reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All treated participants
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs)
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 28 days (CC-122) or 90 days (nivolumab) post-last dose (up to 2 years)Population: All treated participants
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
7 Number of participants
|
9 Number of participants
|
5 Number of participants
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Participants with Grade 3-4 TEAEs
|
7 Number of participants
|
6 Number of participants
|
4 Number of participants
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Participants with Grade 5 TEAEs
|
2 Number of participants
|
0 Number of participants
|
3 Number of participants
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Participants with serious TEAEs
|
6 Number of participants
|
5 Number of participants
|
4 Number of participants
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Participants with TEAE leading to discontinuation of CC-122
|
2 Number of participants
|
1 Number of participants
|
3 Number of participants
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Participants with TEAE leading to discontinuation of nivolumab
|
1 Number of participants
|
1 Number of participants
|
3 Number of participants
|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Participants with TEAE leading to discontinuation of both study drugs
|
1 Number of participants
|
1 Number of participants
|
2 Number of participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: All treated participants
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).
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
0 Percentage of participants
Interval 0.0 to 33.6
|
0 Percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: All treated participants
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).
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Disease Control Rate (DCR) by RECIST 1.1
|
71.4 Percentage of participants
Interval 29.0 to 96.3
|
44.4 Percentage of participants
Interval 13.7 to 78.8
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: All treated participants
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Duration of Response (DoR) by RECIST 1.1
|
NA Days
Median not reached as insufficient progression events among responders
|
NA Days
Median not reached as insufficient progression events among responders
|
NA Days
Median not reached as insufficient progression events among responders
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: All treated participants
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Progression-Free Survival (PFS) by RECIST 1.1
|
130.0 Days
Interval 42.0 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
95.0 Days
Interval 51.0 to 144.0
|
122.0 Days
Interval 56.0 to 166.0
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: All treated participants
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Overall Survival (OS) by RECIST 1.1
|
320.0 Days
Interval 96.0 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
303.0 Days
Interval 196.0 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
135.0 Days
Interval 95.0 to 387.0
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: All treated participants
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=7 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=5 Participants
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.
|
|---|---|---|---|
|
Time to Progression (TTP) by RECIST 1.1
|
NA Days
Interval 42.0 to
Median not reached as insufficient progression events among responders
|
95.0 Days
Interval 51.0 to 144.0
|
166.0 Days
Interval 56.0 to 166.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=2 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=1 Participants
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.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
56.3 ng/mL
Geometric Coefficient of Variation 48.4
|
81.0 ng/mL
Geometric Coefficient of Variation 32.8
|
82.6 ng/mL
Geometric Coefficient of Variation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=2 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=1 Participants
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.
|
|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC)
|
235.3 h*ng/mL
Geometric Coefficient of Variation 17.3
|
399.8 h*ng/mL
Geometric Coefficient of Variation 29.7
|
257.9 h*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=2 Participants
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 3mg + Nivolumab
n=9 Participants
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 4mg + Nivolumab
n=1 Participants
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.
|
|---|---|---|---|
|
Time to Maximum Concentration (Tmax)
|
0.5 hour
Interval 0.5 to 0.5
|
1.0 hour
Interval 0.5 to 2.0
|
1.0 hour
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
n=2 Participants
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 3mg + Nivolumab
n=8 Participants
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 4mg + Nivolumab
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.
|
|---|---|---|---|
|
Terminal Half-life (T-HALF)
|
8.4 hour
Geometric Coefficient of Variation 61.4
|
6.4 hour
Geometric Coefficient of Variation 42.1
|
—
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
CC-122 2mg + Nivolumab
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 3mg + Nivolumab
n=1 Participants
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 4mg + Nivolumab
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.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
—
|
40.1 liter
Geometric Coefficient of Variation NA
Only 1 participant value
|
—
|
Adverse Events
CC-122 2mg + Nivolumab
Serious events: 6 serious events
Other events: 7 other events
Deaths: 4 deaths
CC-122 3mg + Nivolumab
Serious events: 5 serious events
Other events: 9 other events
Deaths: 6 deaths
CC-122 4mg + Nivolumab
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
CC-122 2mg + Nivolumab
n=7 participants at risk
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 3mg + Nivolumab
n=9 participants at risk
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 4mg + Nivolumab
n=5 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
General disorders
Disease progression
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
General disorders
General physical health deterioration
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
40.0%
2/5 • 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).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Abdominal wall abscess
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Herpes zoster
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Infections and infestations
Peritonitis bacterial
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
20.0%
1/5 • 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).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
Other adverse events
| Measure |
CC-122 2mg + Nivolumab
n=7 participants at risk
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 3mg + Nivolumab
n=9 participants at risk
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 4mg + Nivolumab
n=5 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • 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).
|
22.2%
2/9 • 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).
|
20.0%
1/5 • 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).
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
2/7 • 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).
|
55.6%
5/9 • 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).
|
20.0%
1/5 • 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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.9%
3/7 • 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).
|
22.2%
2/9 • 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).
|
0.00%
0/5 • 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).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Eye disorders
Eyelid rash
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Eye disorders
Lacrimation increased
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
42.9%
3/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Ascites
|
28.6%
2/7 • 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).
|
11.1%
1/9 • 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).
|
40.0%
2/5 • 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).
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • 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).
|
33.3%
3/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • 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).
|
11.1%
1/9 • 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).
|
20.0%
1/5 • 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).
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 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).
|
22.2%
2/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • 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).
|
44.4%
4/9 • 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).
|
20.0%
1/5 • 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).
|
|
General disorders
Asthenia
|
57.1%
4/7 • 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).
|
11.1%
1/9 • 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).
|
20.0%
1/5 • 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).
|
|
General disorders
Chills
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
General disorders
Fatigue
|
0.00%
0/7 • 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).
|
33.3%
3/9 • 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).
|
40.0%
2/5 • 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).
|
|
General disorders
General physical health deterioration
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • 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).
|
44.4%
4/9 • 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).
|
40.0%
2/5 • 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).
|
|
General disorders
Pyrexia
|
14.3%
1/7 • 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).
|
22.2%
2/9 • 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).
|
40.0%
2/5 • 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).
|
|
General disorders
Swelling
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Bronchitis
|
28.6%
2/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Infections and infestations
Conjunctivitis
|
28.6%
2/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Escherichia urinary tract infection
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/7 • 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).
|
22.2%
2/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • 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).
|
11.1%
1/9 • 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).
|
60.0%
3/5 • 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).
|
|
Investigations
Amylase increased
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • 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).
|
11.1%
1/9 • 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).
|
80.0%
4/5 • 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).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Blood bilirubin increased
|
28.6%
2/7 • 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).
|
0.00%
0/9 • 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).
|
40.0%
2/5 • 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).
|
|
Investigations
Blood creatine increased
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Investigations
Blood phosphorus decreased
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Lipase increased
|
28.6%
2/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Investigations
Troponin I increased
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Investigations
Weight decreased
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
20.0%
1/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Nervous system disorders
Encephalopathy
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • 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).
|
22.2%
2/9 • 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).
|
0.00%
0/5 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • 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).
|
22.2%
2/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
14.3%
1/7 • 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).
|
0.00%
0/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
20.0%
1/5 • 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).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • 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).
|
22.2%
2/9 • 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).
|
60.0%
3/5 • 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).
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • 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).
|
11.1%
1/9 • 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).
|
0.00%
0/5 • 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).
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • 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).
|
0.00%
0/9 • 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).
|
20.0%
1/5 • 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).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60