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Phase 3Recruiting

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

Sponsored by Merck Sharp & Dohme LLC

About this study

Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment

This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.

Where this study is enrolling (27)

  • University of Alabama- Birmingham ( Site 5015)

    Birmingham, Alabama

    Call 205-934-4011

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  • Florida Cancer Specialists - South ( Site 7001)

    Fort Myers, Florida

    Call 239-274-9930

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  • Mount Sinai Comprehensive Cancer Center ( Site 6000)

    Miami Beach, Florida

    Call 305-674-2625

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  • Florida Cancer Specialists - East ( Site 7000)

    West Palm Beach, Florida

    Call 561-366-4100

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  • Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)

    Miami Beach, Florida

    Call 305-674-2625

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Show all 27 locations

  • Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)

    Savannah, Georgia

    Call 912-819-5789

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  • Winship Cancer Institute of Emory University ( Site 5005)

    Atlanta, Georgia

    Call 404-778-1900

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  • TRIALS 365 ( Site 6008)

    Shreveport, Louisiana

    Call 318-408-1198

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  • Maryland Oncology Hematology (MOH) ( Site 8001)

    Columbia, Maryland

    Call 410-964-2212

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  • Minnesota Oncology Hematology, PA ( Site 8003)

    Edina, Minnesota

    Call 952-928-2944

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  • Women's Cancer Center of Nevada ( Site 6011)

    Las Vegas, Nevada

    Call 702-851-4672

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  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039)

    Mineola, New York

    Call 516-663-3696

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  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)

    New York, New York

    Call 212-404-4434

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  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002)

    Columbus, Ohio

    Call 800-293-5066

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  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)

    Tulsa, Oklahoma

    Call 918-505-3200

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  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)

    Eugene, Oregon

    Call 541-683-5001

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  • Asplundh Cancer Pavilion ( Site 5002)

    Willow Grove, Pennsylvania

    Call 215-481-4000

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  • Honickman Center ( Site 5033)

    Philadelphia, Pennsylvania

    Call 215-955-6923

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  • Women & Infants Hospital ( Site 6003)

    Providence, Rhode Island

    Call 401-430-4818

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  • University of Tennessee Medical Center ( Site 6012)

    Knoxville, Tennessee

    Call 865-305-4893

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  • Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)

    Houston, Texas

    Call 832.556.6936

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  • Texas Oncology - DFW ( Site 8005)

    Fort Worth, Texas

    Call 817-413-1500

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  • Texas Oncology-The Woodlands ( Site 8000)

    The Woodlands, Texas

    Call 281-296-0365

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  • Texas Oncology - Northeast Texas ( Site 8002)

    Tyler, Texas

    Call 903-579-9800

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  • University of Virginia Cancer Center ( Site 6014)

    Charlottesville, Virginia

    Call 434-243-8109

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  • University of Virginia Cancer Center ( Site 5044)

    Charlottesville, Virginia

    Call 434-243-8109

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  • Inova Schar Cancer Institute ( Site 5045)

    Fairfax, Virginia

    Call 571-472-4724

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Who can participate

Inclusion criteria

  • ✓include but are not limited to the following:
  • ✓Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
  • ✓Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \[FIGO\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
  • ✓If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
  • ✓If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
  • ✓If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
  • ✓Has an Eastern Cooperative Oncology Group performance status of 0 or 1
  • ✓Has tumor programmed cell death ligand 1 expression of combined positive score ≥1
  • ✓The main

Exclusion criteria

  • ✕include but are not limited to the following:
  • ✕Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • ✕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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • ✕Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • ✕Has received prior systemic anticancer therapy other than what is specified in this protocol
  • ✕Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
  • ✕Has a diagnosis of immunodeficiency
  • ✕Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • ✕Has known active central nervous system metastases and/or carcinomatous meningitis
  • ✕Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • ✕Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
  • ✕Has a history of stem cell/solid organ transplant
  • ✕Has not adequately recovered from major surgery or has ongoing surgical complications

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.