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)

Running, not enrolling · Phase 3

Conditions studied: Endometrial Neoplasms

In brief

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

Key facts

Study ID: NCT05173987
Run by: Merck Sharp & Dohme LLC
People needed: 280
Starts: 2022-02-03
Expected to finish: 2027-05-27
Last updated by the study team: 2026-05-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.
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.
Has received no prior systemic therapy for EC except for the following:
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.
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.
May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
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).
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.
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.
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.
If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.

You may not qualify if…

Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
Has EC of any histology that is proficient mismatch repair (pMMR).
Is a candidate for curative-intent surgery or curative-intent radiotherapy.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).
Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
Has known active CNS metastases and/or carcinomatous meningitis.
Has a known intolerance to any study intervention and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection, requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has had an allogenic tissue/solid organ transplant.

Where it is running

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

Full record on ClinicalTrials.gov

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