Trial Outcomes & Findings for Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma (NCT NCT03834623)

Last Updated: 2022-10-05

Results Overview

Objective Response Rate of CC-122 in combination with Nivolumab in both anti-PD1 therapy naive advanced melanoma as well as anti-PD1 therapy refractory melanoma (primary refractory or progressing after an initial response or stable disease)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 52 weeks

Results posted on

2022-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Anti-PD1 Naive Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Overall Study STARTED	11	12
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Anti-PD1 Naive Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Overall Study Progression	0	1

Baseline Characteristics

Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Anti-PD1 Naive n=11 Participants Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 Participants Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Outcome measures

Outcome measures
Measure	Cohort 1: Anti-PD1 Naive n=11 Participants Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 Participants Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Objective Response Rate of CC-122 in Combination With Nivolumab	.545 proportion of participants Interval 0.23 to 0.83	0 proportion of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 52 weeks

All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. This will include all events considered possibly, probably or definitely related to study therapy.

Outcome measures

Outcome measures
Measure	Cohort 1: Anti-PD1 Naive n=11 Participants Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 Participants Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Number of Participants Who Experience Treatment Related Adverse Events	11 participants	12 participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and and iRECIST (Response Evaluation Criteria in Solid Tumors in immunotherapy) guidelines v1.1. Results will be indicated as number of participants with evaluable tumor response.

Outcome measures

Outcome measures
Measure	Cohort 1: Anti-PD1 Naive n=11 Participants Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 Participants Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Tumor Response	11 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Progression free survival will be calculated from the start of study therapy till the first documentation of disease progression, death, or change of treatment. Subjects receiving ongoing therapy at the time of data analysis will be censored

Outcome measures

Outcome measures
Measure	Cohort 1: Anti-PD1 Naive n=11 Participants Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 Participants Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Progression Free Survival	NA months Interval 5.7 to Not reached, participants not followed for survival beyond 24 months.	2.7 months Interval 2.7 to Not reached, participants not followed for survival beyond 24 months.

SECONDARY outcome

Timeframe: Up to 24 months

Overall survival will be calculated from the start of therapy till death from any cause. Subjects alive at the time of data analysis will be censored.

Outcome measures

Outcome measures
Measure	Cohort 1: Anti-PD1 Naive n=11 Participants Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 Participants Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
Overall Survival	NA months Interval 24.0 to Not reached, participants not followed beyond 24 months	11.5 months Interval 5.5 to Not reached, participants not followed beyond 24 months

Adverse Events

Cohort 1: Anti-PD1 Naive

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 2: Anti-PD1 Refractory

Serious events: 6 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Nikhil Khushalani, MD

Moffitt Cancer Center

Phone: 813-745-3437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1: Anti-PD1 Naive n=11 participants at risk Anti-PD1 naive participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle	Cohort 2: Anti-PD1 Refractory n=12 participants at risk Anti-PD1 refractory participants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle. CC-122: Oral CC-122 at 2 mg daily, 5 days out of 7 Nivolumab: 240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
General disorders Non-cardiac chest pain	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Other	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	25.0% 3/12 • Number of events 4 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
General disorders Gait disturbance	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Psychiatric disorders Confusion	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 2 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Blood and lymphatic system disorders Anemia	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Infections and infestations Lung infection	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Investigations Cardiac troponin T increased	9.1% 1/11 • Number of events 2 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Vascular disorders Hypertension	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Investigations Creatinine increased	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Cardiac disorders Myocarditis	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Endocrine disorders Adrenal insufficiency	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Cardiac disorders Myocardial infarction	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Nervous system disorders Stroke	9.1% 1/11 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	0.00% 0/12 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Gastrointestinal disorders Gastrointestinal disorders -Other	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.
Infections and infestations Upper respiratory infection	0.00% 0/11 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.	8.3% 1/12 • Number of events 1 • Adverse events collected from time of informed consent to 30 days after study participation, approximately 2.5 years.