A Phase II Study of Rucaparib and Nivolumab Immunotherapy in People with Advanced Leiomyosarcoma

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Phase II Study of Rucaparib and Nivolumab in Patients with Leiomyosarcoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the drugs rucaparib and nivolumab immunotherapy in patients with advanced, inoperable leiomyosarcoma. Researchers believe this drug combination may boost the immune system and prevent the growth of new cancer cells.

Rucaparib works against cancer by inhibiting a protein called PARP. This protein helps cells, including cancer cells, repair their DNA. Some cancer cells may rely on the PARP protein to repair their DNA and survive. If PARP is blocked, these cells may die. Nivolumab is a medication that boosts the power of the immune system to find and kill cancer cells.

These drugs are used individually to treat other cancers, but their use in combination to treat leiomyosarcoma is considered investigational. Rucaparib 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 leiomyosarcoma that persists despite at least one but no more than three prior regimens of treatment.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • 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 and to inquire about eligibility for this study, please contact Dr. Sujana Movva at 646-888-6787.

Protocol

20-358

Phase

II

Investigator

Co-Investigators