NCT04633278

CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Former Sponsor Checkmate Pharmaceuticals

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	CMP-001	Subjects will receive CMP-001 10mg weekly for 2 doses after which CMP-001 will be administered every 3 weeks. The first dose of CMP-001 may be administered subcutaneously (SC) or Intratumorally (IT) at the discretion of Investigator. All subsequent doses will be injected intratumorally every 3 weeks (Q3W).
DRUG	Pembrolizumab	Pembrolizumab 200 mg IV is administered Q3W.

Timeline

• Start date: 2021-01-21
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2020-11-18
• Last updated: 2025-05-11
• Results posted: 2025-04-08

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study