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RecruitingInterventionalPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

NCT ID: NCT07216703Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-12

Summary

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

Detailed description

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.

Arms & interventions

  • BiologicalPembrolizumab

    Intravenous (IV) Infusion

  • BiologicalSacituzumab Tirumotecan

    IV Infusion

  • BiologicalBevacizumab

    IV Infusion

  • DrugPaclitaxel

    IV Infusion

  • DrugCisplatin

    IV Infusion

  • DrugCarboplatin

    IV Infusion

  • DrugRescue Medications

    Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).

Outcome measures

Primary

  • Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Time frame: Up to approximately 69 months

  • Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Time frame: Up to approximately 66 months

  • Part 2 Maintenance Treatment: 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)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by RECIST 1.1 as evaluated by BICR. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Time frame: Up to approximately 48 months

  • Part 2 Maintenance Treatment: Overall Survival (OS)

    OS is defined as time from randomization to death due to any cause. OS will be presented.

    Time frame: Up to approximately 60 months

Secondary

  • Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator

    Time frame: Up to approximately 60 months

  • Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs

    Time frame: Up to approximately 64 months

  • Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 61 months

  • Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score

    Time frame: Baseline and up to approximately 58 months

  • Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score

    Time frame: Baseline and up to approximately 58 months

  • Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score

    Time frame: Baseline and up to approximately 58 months

  • Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score

    Time frame: Baseline and up to approximately 58 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
The main 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

Study locations (16)

Mount Sinai Comprehensive Cancer Center ( Site 6000)

Miami Beach, Florida, 33140

Recruiting
Study Coordinator · Contact

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, 33401

Recruiting
Study Coordinator · Contact

Winship Cancer Institute of Emory University ( Site 5005)

Atlanta, Georgia, 30308

Recruiting
Study Coordinator · Contact

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

Savannah, Georgia, 31405

Recruiting
Study Coordinator · Contact

TRIALS 365 ( Site 6008)

Shreveport, Louisiana, 71103

Recruiting
Study Coordinator · Contact

Minnesota Oncology Hematology, PA ( Site 8003)

Edina, Minnesota, 55435

Recruiting
Study Coordinator · Contact

Women's Cancer Center of Nevada ( Site 6011)

Las Vegas, Nevada, 89106

Recruiting
Study Coordinator · Contact

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

New York, New York, 10016

Recruiting
Study Coordinator · Contact

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

Tulsa, Oklahoma, 74146

Recruiting
Study Coordinator · Contact

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

Eugene, Oregon, 97401

Recruiting
Study Coordinator · Contact

Women & Infants Hospital ( Site 6003)

Providence, Rhode Island, 02905

Recruiting
Study Coordinator · Contact

University of Tennessee Medical Center ( Site 6012)

Knoxville, Tennessee, 37920

Recruiting
Study Coordinator · Contact

Texas Oncology - DFW ( Site 8005)

Fort Worth, Texas, 76104

Recruiting
Study Coordinator · Contact

Texas Oncology-The Woodlands ( Site 8000)

The Woodlands, Texas, 77380

Recruiting
Study Coordinator · Contact

Texas Oncology - Northeast Texas ( Site 8002)

Tyler, Texas, 75702

Recruiting
Study Coordinator · Contact

University of Virginia Cancer Center ( Site 6014)

Charlottesville, Virginia, 22908

Recruiting
Study Coordinator · Contact