Loading clinical trials...
Loading clinical trials...
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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner MD Anderson Cancer Center
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, Los Angeles
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Georgetown
Washington D.C., District of Columbia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Start Date
April 12, 2016
Primary Completion Date
December 6, 2022
Completion Date
December 6, 2022
Last Updated
July 4, 2025
199
ACTUAL participants
CMP-001
DRUG
Pembrolizumab
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
NCT06066138
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions