NRG-GY018: 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

About this Study

The purpose of this study is to see 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).

Sponsor Protocol ID:NRG GY0018
IRB Number:2019-0227
Actively Enrolling
Phase 3
June 15, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Must have measurable stage III, IVA, IVB or recurrent endometrial cancer
  • Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (NOS) are allowed
  • No prior chemotherapy for endometrioid cancer
  • May have received prior adjuvant chemotherapy provided chemotherapy was completed greater than or equal to 12 months prior to STEP 2 registration
  • May have received prior radiation therapy for treatment of endometrial cancer
  • May have received prior hormonal therapy
  • HIV infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 2 registration are allowed

Exclusion Criteria
  • Prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents
  • History of severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475); and/or a severe hypersensitivity reaction to paclitaxel and/or carboplatin
  • Currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to STEP 2 registration
  • Patients show have diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to STEP2 registration
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, and cirrhosis
  • Pregnant or lactating patients