A Phase III Study Comparing Cobimetinib/Atezolizumab Immunotherapy, Atezolizumab Alone, and Regorafenib Alone in Patients with Locally Advanced or Metastatic Colorectal Cancer

Full Title

A Phase III, Open-Label, Multicenter, Three-Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy vs. Regorafenib in Patients with Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Adenocarcinoma

Purpose

In this study, researchers want to see if combining atezolizumab and cobimetinib is more effective than atezolizumab alone or another drug, regorafenib, in patients with locally advanced or metastatic colorectal cancer that persists despite prior chemotherapy. Regorafenib is already used to treat colorectal cancer and is taken orally (by mouth). Patients will be randomly assigned to receive atezolizumab with cobimetinib, atezolizumab alone, or regorafenib alone.

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 cancer; its use in this study is considered investigational. It is given intravenously (by vein).

Cobimetinib works by inhibiting MEK, a protein which fuels cancer growth. It is approved for treating advanced melanoma. It is taken orally. It may also strengthen the immune system's ability to fight cancer.

Eligibility

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

  • Patients must have locally advanced or metastatic colorectal cancer that persists despite at least two prior regimens of chemotherapy.
  • At least 2 weeks must pass since the completion of prior chemotherapy and 3 weeks since any major surgery or radiation therapy and entry into the study.
  • Patients may not have previously received immunotherapy, a MEK inhibitor, or regorafenib.
  • 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

16-1141

Phase

III

Investigator

Co-Investigators

Locations