Immunotherapy in Patients with Advanced Prostate Cancer and Other Metastatic Cancers and CDK12 Mutations

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IMPACT: Immunotherapy in Patients with Metastatic Cancers and CDK12 Mutations

Purpose

The purpose of this study is to assess the effectiveness of combination immunotherapy with nivolumab and ipilimumab in patients with metastatic castration-resistant prostate cancer and other metastatic solid tumors that contain CDK12 mutations. Nivolumab alone is already used to treat many types of solid tumors, and is used in combination with ipilimumab to treat metastatic melanoma. Both drugs work by taking the brakes off the immune response, boosting its power to find and kill cancer cells.

Cancer is caused by changes (mutations) in the genes that control the way cells work, especially the way cells repair mistakes that develop in their DNA. Some of these mistakes cause cancer. Cells have a “proofreading” system to fix DNA mistakes, and the gene CDK12 is part of that system. But cancer cells that have a broken (mutated) form of CDK12 can’t fix DNA mistakes, which makes them different from other cells and may make them sensitive to immunotherapy.

Nivolumab and ipilimumab are both 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 metastatic castration-resistant prostate cancer or another metastatic solid tumor and CDK12 mutations.
  • At least 2 weeks must pass between the completion of prior treatment and entry into the study. Prior immunotherapy with drugs similar to nivolumab and ipilimumab is not permitted.
  • 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. Wassim Abida at 646-422-4633.

Protocol

19-035

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators