A Phase IB/II Study Assessing Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Colorectal Cancer

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Full Title

CO39612: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

Purpose

This study is assessing the safety and effectiveness of three different treatment combinations in patients with metastatic colorectal cancer that continues to grow despite prior treatment. Patients will be randomly assigned to one of these three treatment groups:

  • Regorafenib, a standard treatment for advanced colorectal cancer that blocks an enzyme cancer cells need to grow
  • The immunotherapy drugs atezolizumab and isatuximab in combination. Atezolizumab takes the brakes off the immune response by blocking a protein called PD-L1, allowing the immune system to detect and destroy cancer cells. Isatuximab is an antibody that binds to the CD38 protein on cancer cells. CD38 alters the environment around cancer cells to allow the immune system to recognize and attack cancer.
  • Atezolizumab and Imprime PGG immunotherapy combined with bevacizumab. Bevacizumab blocks the growth of blood vessels cancer cells need to grow and spread. Imprime PGG is a molecule that may act as a switch to help the body recognize and kill tumor cells. When given with atezolizumab and bevacizumab, Imprime PGG may boost the immune system’s ability to fight colorectal cancer.

Atezolizumab, isatuximab, bevacizumab, and Imprime PGG are given intravenously (by vein). Regorafenib is taken orally (by mouth). The use of these medications in this study is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in this study must have metastatic colorectal cancer that has continued to grow despite prior treatment. Additional eligibility criteria apply for each treatment group; investigators will determine each patient’s eligibility during the screening stage of the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please call 646-888-4187.

Protocol

19-027

Phase

I/II

Investigator

Co-Investigators