A Phase III Study of Nivolumab Immunotherapy Alone, Nivolumab with Ipilimumab Immunotherapy, or Chemotherapy in People with Metastatic Colon Cancer

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Full Title

A Phase 3b Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or an Investigator’s Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Purpose

Deficient mismatch repair (dMMR) happens when a cell becomes unable to repair mistakes that happen during the normal process of cell division. The purpose of this study is to find out if nivolumab immunotherapy alone or with ipilimumab immunotherapy is as effective or more effective than standard chemotherapy for patients with dMMR metastatic colon cancer.

Nivolumab and ipilimumab both work by blocking proteins that normally put the brakes on the immune response. By releasing these brakes, the immune system can identify and kill cancer cells. Patients will be randomly assigned to one of three treatment groups:

  • Nivolumab alone
  • Nivolumab plus ipilimumab
  • Standard chemotherapy

Patients in the standard chemotherapy group whose cancer continues to grow may have the option to receive nivolumab and ipilimumab instead. All medications 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 dMMR metastatic colon cancer.
  • At least 2 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients may not have previously received immunotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 and to inquire about eligibility for this study, please contact Dr. Neil Segal at 646-888-4187.

Protocol

19-406

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators