A Phase II Study of BMS-986205 plus Nivolumab Immunotherapy versus Nivolumab Alone for Recurrent or Persistent Endometrial Cancer or Endometrial Carcinosarcoma

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Full Title

A Phase II Trial of IDO-Inhibitor, BMS-986205, and PD-1 Inhibitor, Nivolumab, in Patients with Recurrent or Persistent Endometrial Cancer or Endometrial Carcinosarcomas (CA017-056)

Purpose

The purpose of this study is to see if treatment with the investigational drug BMS-986205 plus nivolumab immunotherapy is more effective than nivolumab alone in women with endometrial cancer or endometrial carcinosarcoma that came back or continues to grow despite treatment. BMS-986205 works by blocking IDO1, a protein that can cause the immune system to slow or shut down. Blocking IDO1 may help the immune system fight cancer cells.

Nivolumab also works by taking the brakes off the immune response (through a different mechanism), boosting the ability of immune cells to detect and destroy cancer cells. It is hoped that using these two drugs together result in an even strong anticancer immune response.

Patients will be randomly assigned to receive BMS-986205 plus nivolumab or nivolumab alone. BMS-986205 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 endometrial cancer or endometrial carcinosarcoma that came back or continues to grow despite prior treatment.
  • Patients’ tumors must have a genetic change called microsatellite instability (MSI) or DNA mismatch repair (MMR).
  • At least 3 weeks must pass since the completion of previous therapies and entry into the study.
  • 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chrisann Kyi at 646-888-4221.

Protocol

19-232

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators