A Phase III Study of Standard Chemotherapy Alone or with Atezolizumab Immunotherapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

Full Title

Alliance A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair (A021502)(CIRB)

Purpose

About one in ten people with stage III colon cancer has deficient “DNA mismatch repair.” This means they lack the ability to correct errors made during copying of DNA (genetic material), resulting in mutations that can fuel cancer growth. In this study, researchers want to see if adding the immunotherapy drug atezolizumab to standard chemotherapy after colon cancer surgery is more effective for preventing cancer recurrence than chemotherapy alone in patients with stage III colon cancer (cancer that has spread to the lymph nodes).

Patients will be randomly assigned to receive standard chemotherapy (a combination of drugs called FOLFOX) alone or with atezolizumab. Atezolizumab boosts the power of the immune system to find and kill cancer cells by inhibiting a protein called PD-L1. Atezolizumab is approved for treating bladder and lung cancers; its use in this study is considered investigational. The medications used in this study 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 operable stage III colon cancer with deficient DNA mismatch repair.
  • Patients may not have had any medical therapy or radiation therapy prior to entering the study, with the exception of one cycle of mFOLFOX6 chemotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Zsofia Stadler at 646-888-4039.

Protocol

17-651

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

Diaz, Luis, MD