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NCT04350463 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT04350463 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 92 participants.
The verdict
NCT04350463, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nivolumab
- DRUG CC-90011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2023-12-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04350463
The ClinicalTrials.gov registry entry for NCT04350463 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04350463 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04350463 about?
NCT04350463 is a clinical study titled "A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers". 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 st...
What is the current status of trial NCT04350463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2020-07-14. Estimated completion is 2023-12-19.
What interventions are being tested in trial NCT04350463?
The interventions under investigation include: Nivolumab (DRUG), CC-90011 (DRUG).
Who is sponsoring clinical trial NCT04350463?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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