A Phase III Study of Standard Chemotherapy with or without Pembrolizumab Immunotherapy to Treat Advanced or Recurrent Endometrial Cancer

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Full Title

A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer (CIRB)

Purpose

Paclitaxel and carboplatin are standard chemotherapy drugs used to treat advanced endometrial (uterine) cancer. In this study, researchers want to learn if adding the immunotherapy drug pembrolizumab to this chemotherapy combination is more effective than the chemotherapy alone.

Pembrolizumab works by boosting the ability of the immune system to detect and destroy cancer cells. Patients in this study will be randomly assigned to receive paclitaxel and carboplatin with either pembrolizumab or a placebo for four and a half months, followed by pembrolizumab or a placebo for up to two years. All treatments are 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 stage III or IV or recurrent endometrial cancer.
  • If patients received prior therapy, at least 1 year must pass since prior paclitaxel/carboplatin chemotherapy, 4 weeks since completion of radiation therapy, and 3 weeks since receiving hormonal therapy and entry into the study.
  • Patients may not have previously received immunotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Carol Aghajanian at 646-888-4217.

Protocol

19-327

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators