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NCT04695977 · ClinicalTrials.gov registry record · Phase 2
CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04695977: Clinical Trial Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT04695977 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04695977, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma. The secondary objectives of Phase 3 are to: * To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. * To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
Primary Outcome
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)
Interventions
- DRUG Nivolumab
- DRUG CMP-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2024-07-22 |
| Phase | Phase 2 |
Why NCT04695977 stopped before completion
NCT04695977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04695977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04695977 about?
NCT04695977 is a clinical study titled "CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma". CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. The primary objective of Phase 2 of the s...
What is the current status of trial NCT04695977?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-02-24. Estimated completion is 2024-07-22.
What interventions are being tested in trial NCT04695977?
The interventions under investigation include: Nivolumab (DRUG), CMP-001 (DRUG).
Who is sponsoring clinical trial NCT04695977?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04695977's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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