A Multicenter, Open-label, Phase 2 Study of Intratumoral CMP-001 in Combination With an Intravenous PD-1-Blocking Antibody in Subjects With Selected Types of Advanced or Metastatic Cancer

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    279
  • sponsor
    Regeneron Pharmaceuticals
Updated on 22 September 2022
cancer

Summary

CMP-001-009 is a Phase 2 study of intratumoral CMP-001 in combination with an intravenous PD-1-blocking antibody administered to participants with certain types of advanced or metatastic cancer.

The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with a programmed cell death protein (PD-1)-blocking antibody in subjects with certain types of advanced or metatastic cancer.

The secondary objectives are to:

  • To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with a PD-1-blocking antibody in study subjects.
  • To evaluate the efficacy of CMP-001 in combination with a PD-1-blocking antibody in study subjects.

Participants will continue to receive treatment of CMP-001 in combination with a PD-1-blocking antibody according to the treatment schedule until a reason for treatment discontinuation is reached.

Description

Former Sponsor Checkmate Pharmaceuticals

Details
Condition Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Metastatic Cancer, Triple Negative Breast Cancer, Advanced Cancer
Treatment CMP-001, Cemiplimab-Rwlc
Clinical Study IdentifierNCT04916002
SponsorRegeneron Pharmaceuticals
Last Modified on22 September 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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