NCT03084640

Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Participants With Advanced Melanoma

A Multicenter, Two Part, Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Subjects With Advanced Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CMP-001-002 is a Phase 1b study of CMP-001 administered to participants with advanced melanoma who are either receiving pembrolizumab, or who have previously received an anti-programmed cell death protein 1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) therapy for advanced melanoma, and who have not responded (that is, immunotherapy resistant). This study will be conducted in two parts: Part 1 will consist of a Dose Escalation Phase and a Dose Expansion Phase * Dose Escalation Phase will be conducted to assess and identify a recommended phase 2 dose (RP2D) of CMP-001 for subcutaneous (SC) administration * The Dose Expansion Phase is intended to further characterize the safety, pharmacodynamics, and preliminary evidence of antitumor activity of the RP2D of CMP-001 administered SC in combination with pembrolizumab Part 2 will assess the safety and preliminary evidence of antitumor activity of CMP-001, administered both SC and intratumoral (IT) when given in combination with pembrolizumab. Participants will continue treatment with CMP-001 in combination with pembrolizumab as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator.

Detailed description

Former Sponsor Checkmate Pharmaceuticals

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	CMP-001	CMP-001 will be administered SC as per the dose and schedule specified in the respective arms.
DRUG	Pembrolizumab	Pembrolizumab will be administered as per the schedule specified in the respective arms.
DRUG	CMP-001	CMP-001 will be administered IT as per the dose and schedule specified in the respective arms.

Timeline

• Start date: 2017-05-04
• Primary completion: 2021-07-02
• Completion: 2021-09-30
• First posted: 2017-03-21
• Last updated: 2022-08-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study