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

NCT02680184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2025-07-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CMP-001

CMP-001 will be administered 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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-12
Primary Completion
2022-12-06
Completion
2022-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680184 on ClinicalTrials.gov