A Phase IB Study of Cobimetinib with Bevacizumab and Atezolizumab Immunotherapy in Patients with Progressive Metastatic Colorectal Cancer

Full Title

A Phase Ib Open-Label Study Evaluating the Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Bevacizumab and Immunotherapy When Administered in Patients With Gastrointestinal and Other Tumors

Purpose

In this study, researchers are evaluating the safety and preliminary effectiveness of combining the drug cobimetinib with atezolizumab and bevacizumab in patients with metastatic colorectal cancer that has continued to grow despite prior treatment. Cobimetinib works by inhibiting MEK, a protein which fuels cancer growth. It may also strengthen the immune system’s ability to fight cancer. Its use in this study is considered investigational. Cobimetinib is taken orally.

Atezolizumab is an immunotherapy drug designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. It is approved for treating bladder and lung cancers; its use in this study is investigational. Bevacizumab is an anticancer drug that interferes with the development of the blood vessels that cancers need to grow and spread; it is already used to treat advanced colorectal cancer. Both of these drugs are given intravenously (by vein).

Eligibility

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

  • Patients must have inoperable metastatic colorectal cancer that is continuing to grow despite prior treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

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

Protocol

17-023

Phase

I/II

Investigator

Co-Investigators