A Phase II Study of Temozolomide, Cisplatin, and Nivolumab Immunotherapy in Colorectal Cancer

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Full Title

A Phase II Study of Temozolomide, Cisplatin and Nivolumab in MMR-Proficient Colorectal Cancer

Purpose

With mismatch repair-proficient (MMR-proficient) cancers, there are no abnormalities with a system in the body that keeps genes or DNA stable. MMR-proficient colorectal cancer is usually treated with chemotherapy but not with immunotherapy (treatment that boosts the body’s natural defenses to fight cancer).

Researchers think the combination of the chemotherapy drugs cisplatin and temozolomide plus the immunotherapy drug nivolumab could be an effective treatment for MMR-proficient colorectal cancer. This study will look at how effective and safe this drug combination is in people with MMR-proficient colorectal cancer.

These drugs are used to treat cancer, but their use in combination is considered investigational. Cisplatin and nivolumab are given intravenously (by vein) and temozolomide is taken orally (by mouth).

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 chemotherapy.
  • At least two weeks must pass between the completion of previous therapy and receipt of the study treatment. Prior immunotherapy is not permitted.
  • 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 about this study and to inquire about eligibility, please contact Dr. Neil Segal at 646-888-4187.

Protocol

20-202

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diaz, Luis, MD