Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633278
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2020-10-26
Brief Title:
CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Multicenter Phase 2 Open-label Study of Intratumoral CMP-001 in Combination With Intravenous Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Former Sponsor Checkmate Pharmaceuticals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None