A Phase III Study of MK-4280A Immunotherapy Versus Standard Treatment for Previously Treated Metastatic Colorectal Cancer

Share

Full Title

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PDL1 Positive Colorectal Cancer (WIRB)

Purpose

The purpose of this study is to compare the effectiveness of the investigational drug MK-4280A with standard therapies for metastatic colorectal cancer that contains the PD-L1 protein. MK-4280A is an immunotherapy that combines two drugs: favezelimab and pembrolizumab. These medications work by boosting the ability of the immune system to find and kill cancer cells.

Participants in this study will be randomly assigned to receive MK-4280A or one of two standard therapies: regorafenib or TAS-102. MK-4280A is given intravenously (by vein) and the standard treatments are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have metastatic colorectal cancer that is positive for PD-L1 and has continued to grow despite prior treatment.
  • Previous immunotherapy is not permitted.
  • At least 4 weeks must pass since the completion of previous therapies and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Neil Segal at 646-888-4187.

Protocol

22-103

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators