Endometrial Cancer NRG GY018

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

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

Eligibility Criteria:

• • Measureable stage III, measurable stage IVA, stage IVB (with or without measureable disease) or recurrent (with or without measureable disease) Endometrial Cancer.
    • Pathology report showing results of institutional MMR IHC testing.
    • Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required).
    • Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.).
  • Submission or tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration.
  • In patients with measureable disease (Stage III or IVA), lesions will be defined and monitored by RECIST 1.1. Each lesion must be > 10mm when measured by CT or MRI. Lymph nodes must be > 15mm in short axis when measured by CT or MRI.
  • No Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti CTLA-4 therapeutic antibody or other similar agents.
  • No Patients who have a history of severe hypersensitivity reaction in monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients.

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut