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NCT04633278 · ClinicalTrials.gov registry record · Phase 2
CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT04633278 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT04633278, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: * To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC * To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC * To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Interventions
- DRUG Pembrolizumab
- DRUG CMP-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04633278
The ClinicalTrials.gov registry entry for NCT04633278 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04633278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04633278 about?
NCT04633278 is a clinical study titled "CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective ...
What is the current status of trial NCT04633278?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2021-01-21. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT04633278?
The interventions under investigation include: Pembrolizumab (DRUG), CMP-001 (DRUG).
Who is sponsoring clinical trial NCT04633278?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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