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Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy

Melanoma Clinical Trial

Official title:
A Multicenter, Two Part Open-Label, Phase 1B Clinical Study of CMP-001 Administered Either in Combination With Pembrolizumab or as a Monotherapy in Subjects With Advanced Melanoma

Clinical Trial Summary

This study will be conducted in two parts: Part 1 will be conducted using a Dose Escalation and Expansion design. The Part 1 Dose Escalation Phase of this study will identify a safe and tolerable dose to be further evaluated in the Part 1 Dose Expansion phase. Part 2 of the study will be conducted in parallel with the Part 1 Dose Expansion Phase and will evaluate the safety and efficacy of CMP-001 when administered as a monotherapy. A Treatment Extension to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy will be available to those who are currently being treated in either Part 1 or Part 2 of this study at the time of protocol Amendment 9, v10.0.

Clinical Trial Description

Former Sponsor Checkmate Pharmaceuticals The primary objective of Part 1 of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of CMP-001 when given in combination with pembrolizumab in participants with advanced melanoma. The primary objective of Part 2 of the study is to assess and describe the safety profile of CMP-001 when administered as monotherapy. The primary objective of the Treatment Extension is to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy in the Treatment Extension. Participants enrolled into either Part 1 or Part 2 will continue study treatment as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator. Participants may continue therapy beyond progression based upon Investigator judgement of potential benefit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02680184
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date April 12, 2016
Completion date December 6, 2022
View Details
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