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Phase 3Recruiting

A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)

Sponsored by Merck Sharp & Dohme LLC

About this study

Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.

All participants undergo an initial Induction Phase of six cycles, each cycle consisting of pembrolizumab + carboplatin or cisplatin + paclitaxel or docetaxel. Each cycle is three weeks. Participants whose cancer does not progress enter the Maintenance Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or pembrolizumab monotherapy. Participants whose cancer does progress will have the possibility to enter the Subsequent Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or sac-TMT monotherapy.

Where this study is enrolling (48)

  • University of South Alabama, Mitchell Cancer Institute ( Site 6033)

    Mobile, Alabama

    Call 251-665-8000

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  • Alaska Women's Cancer Care ( Site 6036)

    Anchorage, Alaska

    Call 907-562-4673

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  • John Muir Health Cancer Center ( Site 6028)

    Walnut Creek, California

    Call 925-674-2580

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  • CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014)

    Irvine, California

    Call 714-456-8000

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  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)

    Orange, California

    Call 949-813-1517

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Show all 48 locations

  • Sansum Clinic (Ridley Tree) ( Site 8007)

    Solvang, California

    Call 805-879-0643

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  • Yale University School of Medicine ( Site 6009)

    New Haven, Connecticut

    Call 203-737-4450

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  • MedStar Washington Hospital Center ( Site 5005)

    Washington D.C., District of Columbia

    Call 202-877-7000

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  • Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)

    Miami Beach, Florida

    Call 305-674-2625

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  • AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)

    Orlando, Florida

    Call 407-609-3462

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  • Florida Cancer Specialists East ( Site 7001)

    West Palm Beach, Florida

    Call 561-366-4100

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  • Florida Cancer Specialists ( Site 7002)

    St. Petersburg, Florida

    Call 727-522-0558

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  • Florida Cancer Specialists - South ( Site 7003)

    Fort Myers, Florida

    Call 239-274-9930

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  • UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)

    Gainesville, Florida

    Call 352-273-7832

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  • St. Joseph's/Candler Health System ( Site 6021)

    Savannah, Georgia

    Call 912-819-5704

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  • University of Chicago Medical Center ( Site 5002)

    Chicago, Illinois

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  • Parkview Research Center ( Site 6008)

    Fort Wayne, Indiana

    Call 800-724-8326

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  • Women's Cancer Care ( Site 6010)

    Covington, Louisiana

    Call 985-317-6005

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  • TRIALS 365 ( Site 6005)

    Shreveport, Louisiana

    Call 318-408-1198

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  • Maine Medical Center - Scarborough Campus ( Site 6042)

    Scarborough, Maine

    Call 207-396-7089

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  • Tufts Medical Center ( Site 6052)

    Boston, Massachusetts

    Call 617-636-2616

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  • Minnesota Oncology Hematology, PA ( Site 8003)

    Minneapolis, Minnesota

    Call 817-837-8660

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  • St. Dominic's Hospital ( Site 5004)

    Jackson, Mississippi

    Call 601-200-4970

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  • Holy Name Medical Center ( Site 6011)

    Teaneck, New Jersey

    Call 201-227-6200

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  • University of New Mexico Comprehensive Cancer Center ( Site 6046)

    Albuquerque, New Mexico

    Call 505-272-4946

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  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)

    New York, New York

    Call 212-731-6455

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  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)

    Mineola, New York

    Call 516-708-4821

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  • Memorial Sloan Kettering Cancer Center ( Site 6053)

    New York, New York

    Call 212-639-2000

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  • Duke Cancer Institute ( Site 6049)

    Durham, North Carolina

    Call 919-684-3780

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  • FirstHealth of the Carolinas ( Site 6037)

    Pinehurst, North Carolina

    Call 910-715-8684

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  • Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001)

    Kettering, Ohio

    Call 937-395-6017

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  • Miami Valley Hospital South ( Site 6014)

    Centerville, Ohio

    Call 937-438-7800

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  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)

    Columbus, Ohio

    Call 614-293-9337

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  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)

    Tulsa, Oklahoma

    Call 918-505-3200

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  • Oncology Associates of Oregon, P.C. ( Site 8005)

    Eugene, Oregon

    Call 541-736-3385

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  • Hospital of the University of Pennsylvania ( Site 5007)

    Philadelphia, Pennsylvania

    Call 215-662-2487

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  • AHN West Penn Hospital ( Site 6006)

    Pittsburgh, Pennsylvania

    Call 412-578-1116

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  • St. Luke's University Health Network ( Site 6041)

    Bethlehem, Pennsylvania

    Call 484-503-4673

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  • Women & Infants Hospital ( Site 5003)

    Providence, Rhode Island

    Call 401-453-7520

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  • Erlanger Medical Center ( Site 5009)

    Chattanooga, Tennessee

    Call 423-778-3902

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  • Texas Oncology - DFW ( Site 8004)

    Fort Worth, Texas

    Call 817-413-1500

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  • Texas Oncology - Northeast Texas ( Site 8002)

    Tyler, Texas

    Call 903-579-9800

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  • Texas Oncology - Gulf Coast ( Site 8006)

    Webster, Texas

    Call 281-332-7505

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  • Houston Methodist Hospital ( Site 6057)

    Houston, Texas

    Call 713.790.3311

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  • Texas Oncology-San Antonio Medical Center ( Site 8001)

    San Antonio, Texas

    Call 210-595-5300

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  • Virginia Cancer Specialists (VCS) ( Site 8008)

    Fairfax, Virginia

    Call 703-280-5390

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  • VCU Health Adult Outpatient Pavillion ( Site 5000)

    Richmond, Virginia

    Call 804-628-4368

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  • Inova Schar Cancer Institute ( Site 6003)

    Fairfax, Virginia

    Call 571-472-4724

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Who can participate

Inclusion criteria

  • ✓include but are not limited to:
  • ✓Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
  • ✓Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator
  • ✓Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment

Exclusion criteria

  • ✕include but are not limited to:
  • ✕Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
  • ✕Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
  • ✕Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment
  • ✕Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • ✕Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • ✕Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • ✕Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • ✕Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.