A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers
Status:
Recruiting
Trial end date:
2024-09-13
Target enrollment:
Participant gender:
Summary
This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy
of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous
non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.
The primary objectives of the study are to evaluate the overall response rate of subjects
treated with CC-90011 in combination with nivolumab in three cohorts:
- Cohort A: SCLC in ICI naïve subjects
- Cohort B: SCLC in ICI progressor subjects
- Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the
proportion of subjects in the treated population who had complete response (CR) or
partial response (PR) as assessed by Investigator review per RECIST v1.1.
In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To
achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled
according to a 2-stage group sequential design based on a binomial test. In stage 1, 12
subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there
are 2 or more subjects responding, Cohort A will continue to enroll an additional 27
subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility.
In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To
achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled
according to a 2-stage group sequential design based on a binomial test. In stage 1, 14
subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there
are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34
subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.