Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) (NCT05173987)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
2. Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
3. Has received no prior systemic therapy for EC except for the following:
4. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred ≥6 months after the last dose of chemotherapy.
5. May have received prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
6. May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization.
7. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
8. Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
9. Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
10. Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
11. If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
12. If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (194 Sites)

• HonorHealth-USOR HonorHealth ( Site 8000) — Phoenix, Arizona
• Moores Cancer Center ( Site 0037) — La Jolla, California
• Kaiser Permanente Riverside Medical Center ( Site 0045) — Riverside, California
• Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013) — New Haven, Connecticut
• Mount Sinai Cancer Center ( Site 0018) — Miami Beach, Florida
• Sarasota Memorial Heath Care System ( Site 0005) — Sarasota, Florida
• Northside Hospital ( Site 0017) — Atlanta, Georgia
• Southeastern Regional Medical Center ( Site 0046) — Newnan, Georgia
• Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003) — Zion, Illinois
• St. Vincent Hospital and Health Care Center, Inc ( Site 0006) — Indianapolis, Indiana
• Baptist Health Lexington ( Site 0042) — Lexington, Kentucky
• Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002) — Rockville, Maryland
• University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008) — Worcester, Massachusetts
• Karmanos Cancer Institute ( Site 0029) — Detroit, Michigan
• St. Dominic's Hospital ( Site 0024) — Jackson, Mississippi
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026) — Hackensack, New Jersey
• The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023) — New York, New York
• Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016) — New York, New York
• Icahn School of Medicine at Mount Sinai ( Site 0052) — New York, New York
• Memorial Sloan Kettering Cancer Center ( Site 0009) — New York, New York
• FirstHealth Clinical Trials ( Site 0050) — Pinehurst, North Carolina
• Sanford Medical Center ( Site 0054) — Bismarck, North Dakota
• Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055) — Fargo, North Dakota
• University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039) — Cincinnati, Ohio
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0027) — Columbus, Ohio

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.