Trial Outcomes & Findings for A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers (NCT NCT04350463)

Last Updated: 2025-01-22

Results Overview

Overall response rate was defined as the percentage of participants in the treated population who had confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

Every 6 weeks post Cycle 1 (each cycle is of 28 days) Day 1 for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participants (up to approximately 33 months)

Results posted on

2025-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A 40 mg Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Overall Study STARTED	39	2	14	37
Overall Study COMPLETED	8	0	0	2
Overall Study NOT COMPLETED	31	2	14	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A 40 mg Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Overall Study Other reason	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	2
Overall Study Withdrawal by Subject	4	0	1	4
Overall Study Adverse Event	0	0	0	2
Overall Study Death	27	2	13	26

Baseline Characteristics

A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=37 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Total n=92 Participants Total of all reporting groups
Age, Customized < 65 years	21 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants	17 participants n=4 Participants	51 participants n=21 Participants
Age, Customized >= 65 - < 75 years	16 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	15 participants n=4 Participants	34 participants n=21 Participants
Age, Customized >= 75 years	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants	7 participants n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	35 Participants n=4 Participants	74 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants	62 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants	23 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants	72 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	20 Participants n=21 Participants

PRIMARY outcome

Timeframe: Every 6 weeks post Cycle 1 (each cycle is of 28 days) Day 1 for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participants (up to approximately 33 months)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Overall Response Rate	10.3 percentage of participants Interval 2.9 to 24.2	0 percentage of participants Interval 0.0 to 84.2	0 percentage of participants Interval 0.0 to 23.2	8.6 percentage of participants Interval 1.8 to 23.1

SECONDARY outcome

Timeframe: From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 1=mild, Grade 2=Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death).

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 1	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 2	14 Participants	0 Participants	2 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3	7 Participants	0 Participants	3 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 4	8 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 5	10 Participants	0 Participants	5 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Missing	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (each cycle is of 28 days)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening).

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 1 Hemoglobin	3 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 1 Leukocytes	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 1 Lymphocytes	5 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 1 Neutrophils	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 1 Platelets	3 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 2 Hemoglobin	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 2 Lymphocytes	3 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 2 Platelets	5 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 3 Lymphocytes	1 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 3 Platelets	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 4 Lymphocytes	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 5 Hemoglobin	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 5 Lymphocytes	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 6 Lymphocytes	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 6 Platelets	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 7 Lymphocytes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 8 Lymphocytes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 8 Platelets	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 9 Lymphocytes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 9 Platelets	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 10 Lymphocytes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 10 Platelets	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 11 Lymphocytes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 12 Hemoglobin	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 14 Platelets	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 18 Neutrophils	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters Cycle 18 Platelets	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (Each cycle is of 28 days)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening).

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 14 Sodium	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 14 Direct Bilirubin	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 16 Potassium	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 6 Calcium	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Alanine Aminotransferase	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Albumin	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Alkaline Phosphatase	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Aspartate Aminotransferase	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Bilirubin	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Direct Bilirubin	1 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 1 Sodium	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 2 Alanine Aminotransferase	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 2 Alkaline Phosphatase	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 2 Aspartate Aminotransferase	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 2 Direct Bilirubin	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 2 Glucose	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 2 Sodium	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 3 Calcium	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 3 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 3 Glucose	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 3 Potassium	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 4 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 4 Sodium	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 5 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 6 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 6 Sodium	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 7 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 8 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 9 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 9 Glucose	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 10 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters Cycle 11 Direct Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab

Concomitant medication is defined as medications that were either initiated before the first dose of study drug and continued during the study treatment, or initiated on/after the date of the first dose of study drug and on/before the date of treatment discontinuation.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants Receiving Concomitant Medication	39 Participants	2 Participants	14 Participants	35 Participants

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 107 weeks)

Population: Treated population consist of all participants who enroll and take at least one dose of either CC-90011 or nivolumab. Participants with weight measurements available at the specific timepoint were analyzed.

Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=32 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=1 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=10 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=21 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Change From Baseline at End of Treatment in Vital Sign - Weight	-1.88 kilogram Standard Deviation 5.583	-1.00 kilogram Standard Deviation NA Standard Deviation is not available as only 1 participant was analyzed.	-2.58 kilogram Standard Deviation 5.651	-4.20 kilogram Standard Deviation 8.065

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 107 weeks)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with DBP and SBP measurements available at the specific timepoint were analyzed.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=31 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=1 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=11 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=24 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Change From Baseline at End of Treatment in Vital Sign - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Systolic Blood Pressure	-8.5 millimeters of mercury (mmHg) Standard Deviation 18.35	5.0 millimeters of mercury (mmHg) Standard Deviation NA Standard Deviation is not available as only 1 participant was analyzed.	4.8 millimeters of mercury (mmHg) Standard Deviation 14.82	-11.2 millimeters of mercury (mmHg) Standard Deviation 15.19
Change From Baseline at End of Treatment in Vital Sign - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Diastolic Blood Pressure	-4.9 millimeters of mercury (mmHg) Standard Deviation 10.84	9.0 millimeters of mercury (mmHg) Standard Deviation NA Standard Deviation is not available as only 1 participant was analyzed.	-3.2 millimeters of mercury (mmHg) Standard Deviation 6.60	-3.1 millimeters of mercury (mmHg) Standard Deviation 9.89

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 107 weeks)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with temperature measurements available at the specific timepoint were analyzed.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=31 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=1 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=11 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=23 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Change From Baseline at End of Treatment in Vital Sign - Temperature	0.01 degree Celsius Standard Deviation 0.376	0.20 degree Celsius Standard Deviation NA Standard Deviation is not available as only 1 participant was analyzed.	0.03 degree Celsius Standard Deviation 0.388	-0.04 degree Celsius Standard Deviation 0.509

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 107 weeks)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with pulse rate measurements available at the specific timepoint were analyzed.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=31 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=1 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=10 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=24 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Change From Baseline at End of Treatment in Vital Sign - Pulse Rate	-1.0 beats per minute Standard Deviation 12.37	-8.0 beats per minute Standard Deviation NA Standard Deviation is not available as only 1 participant was analyzed.	12.0 beats per minute Standard Deviation 14.73	0.4 beats per minute Standard Deviation 16.58

SECONDARY outcome

Timeframe: Baseline and up to End of Treatment (107 weeks)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with ECOG measurements available at the specific timepoint were analyzed.

ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=33 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=1 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=11 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=23 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 4 to Grade 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 1 to Grade 3	0 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 1 to Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 1 to Grade 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 2 to Grade 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 2 to Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 2 to Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 2 to Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 2 to Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 2 to Grade 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 3 to Grade 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 3 to Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 3 to Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 3 to Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 3 to Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 3 to Grade 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 4 to Grade 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 4 to Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 4 to Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 4 to Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 4 to Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 5 to Grade 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 5 to Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 5 to Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 5 to Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 5 to Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 5 to Grade 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 0 to Grade 0	2 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 0 to Grade 1	6 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 0 to Grade 2	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 0 to Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 0 to Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 0 to Grade 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 1 to Grade 0	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 1 to Grade 1	17 Participants	1 Participants	5 Participants	8 Participants
Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status Grade 1 to Grade 2	7 Participants	0 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Treatment-emergent Adverse Events Leading to Dose Reduction of CC-90011	7 Participants	2 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Treatment-emergent Adverse Events Leading to Dose Interruption of CC-90011	27 Participants	1 Participants	6 Participants	26 Participants

SECONDARY outcome

Timeframe: From the start of study drug until 100 days after last dose of Nivolumab (up to 849 days)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Number of Participants With Treatment-emergent Adverse Events Leading to Dose Interruption of Nivolumab	16 Participants	0 Participants	3 Participants	14 Participants

SECONDARY outcome

Timeframe: Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months))

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Treated Population with confirmed Best Response of CR or PR were included in analysis.

Duration of Response was defined as the time from the first occurrence of a confirmed documented response to the time of the first documented tumor progression, as determined by Investigator review per RECIST v1.1, or death from any cause, whichever comes first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=4 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=3 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Duration of Response	645.0 days Standard Deviation 387.05	—	—	326.0 days Standard Deviation 201.14

SECONDARY outcome

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Treated Population with confirmed best response of CR or PR.

Time to response was defined as the time from the first dose of the study drug to the date of the first confirmed documented response (CR or PR), as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=4 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=3 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Time to Response	82.0 days Interval 38.0 to 91.0	—	—	79.0 days Interval 38.0 to 126.0

SECONDARY outcome

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

Progression-Free Survival is the time from first dose of study treatment to the date of the first objectively documented tumor progression as assessed by Investigator review per RECIST v1.1 or death from any cause, whichever occurs first. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Progression-Free Survival	126.4 days Standard Deviation 190.29	33.5 days Standard Deviation 7.78	65.6 days Standard Deviation 57.23	184.9 days Standard Deviation 202.20

SECONDARY outcome

Timeframe: From the first dose of study drug to the date of next cancer therapy or death due to any cause (up to approximately 33 months)

Population: Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab.

Time to First Subsequent Therapy was defined as the time from the first dose of the study drug to the date of the next cancer therapy or death.

Outcome measures

Outcome measures
Measure	Cohort A 40 mg n=39 Participants Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort A 60mg n=2 Participants Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort B 40 mg n=14 Participants Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.	Cohort C n=35 Participants Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion.
Time to First Subsequent Therapy	181.3 days Standard Deviation 183.87	60.0 days Standard Deviation 2.83	113.3 days Standard Deviation 111.51	224.1 days Standard Deviation 203.26

Adverse Events

Cohort A 40 mg

Serious events: 20 serious events

Other events: 39 other events

Deaths: 29 deaths

Cohort A 60mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Cohort B 40 mg

Serious events: 8 serious events

Other events: 14 other events

Deaths: 13 deaths

Cohort C

Serious events: 25 serious events

Other events: 33 other events

Deaths: 32 deaths

Serious adverse events

Other adverse events

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 Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Publication restrictions are in place

Restriction type: OTHER