A Phase III Study Comparing Pembrolizumab Immunotherapy with Chemotherapy in People with Mismatch Repair-Deficient Advanced or Recurrent Endometrial Cancer

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Full Title

A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab vs. Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064) (WIRB)

Purpose

Mismatch repair-deficient cells are unable to repair DNA mistakes made during cell division, which may lead to cancer. In this study, researchers are comparing the effectiveness of pembrolizumab immunotherapy with standard chemotherapy (paclitaxel and carboplatin) in people with mismatch repair-deficient endometrial cancer that has come back or continued to grow despite prior therapy. Pembrolizumab works by boosting the power of the immune system to detect and destroy cancer cells.

Participants in this study will be randomly assigned to receive either pembrolizumab or paclitaxel/carboplatin chemotherapy. Patients in the chemotherapy group will eventually be permitted to receive pembrolizumab if their cancer continues to grow. Both treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage III or IV or recurrent endometrial cancer or carcinosarcoma (mixed Mullerian tumor) that is mismatch repair-deficient.
  • Patients may not have received anticancer medication for advanced endometrial cancer.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Vicky Makker at 646-888-4224.

Protocol

22-143

Phase

III

Investigator

Co-Investigators