A Phase II Study of Temozolomide Followed by Nivolumab Immunotherapy in Patients with Inoperable or Metastatic Colorectal Cancer

Full Title

A Phase II Study of Temozolamide and Nivolumab in MMR-Proficient Colorectal Cancer (CA209-8JN)

Purpose

MMR-proficient colorectal cancer is a type of cancer that is usually treated with chemotherapy but not immunotherapy. MMR is a type of genetic change (mutation) in the tumor. In this study, researchers are assessing the safety and effectiveness of giving the anticancer drug temozolomide followed by the immunotherapy drug nivolumab in patients with MMR-proficient colorectal cancer that persists despite prior treatment.

Temozolomide works by damaging genetic material (DNA) in tumor cells. Researchers think that temozolomide may also cause mutations in a tumor’s DNA, triggering an immune response against cancer and the new mutations caused by the drug. Nivolumab is a drug that takes the brakes off the immune response, enabling the immune system to detect and destroy cancer cells. It may boost the immune system’s ability to attack colorectal cancer cells and the new genetic mutations caused by temozolomide.

Temozolomide is used to treat brain cancer and nivolumab is used to treat multiple other cancers. Their use in this study is considered investigational. Temozolomide is taken orally (by mouth) and nivolumab is 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 or metastatic MMR-proficient colorectal cancer that persists despite at least two prior regimens of standard chemotherapy.
  • At least 2 weeks must pass between the completion of previous treatment and entry into the study.
  • Patients may not have received prior immunotherapy.
  • 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 call 646-888-4187.

Protocol

18-545

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diaz, Luis, MD