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RecruitingInterventionalPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

NCT ID: NCT06824467Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-12

Summary

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Arms & interventions

  • BiologicalSacituzumab tirumotecan

    IV Infusion

  • BiologicalBevacizumab

    IV Infusion

  • DrugH1 receptor antagonist

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • DrugH2 receptor antagonist

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • DrugAcetaminophen (or equivalent)

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • DrugDexamethasone (or equivalent)

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • DrugSteroid mouthwash (dexamethasone or equivalent)

    Rescue medication taken orally 2-4 times daily

Outcome measures

Primary

  • Part 1: Number of participants with 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Time frame: Up to 6 weeks

  • Part 1: Number of participants who discontinue study intervention 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Time frame: Up to 6 weeks

  • Part 2: Progression-free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

    Time frame: Up to approximately 4 years

Secondary

  • Part 2: Overall Survival (OS)

    Time frame: Up to approximately 4 years

  • Part 2: Number of participants with one or more AEs

    Time frame: Up to approximately 4 years

  • Part 2: Number of participants who discontinue study intervention due to an AE

    Time frame: Up to approximately 4 years

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

    Time frame: Baseline and up to approximately 4 years

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

    Time frame: Baseline and up to approximately 4 years

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

    Time frame: Baseline and up to approximately 4 years

  • Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale

    Time frame: Baseline and up to approximately 4 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) * Has platinum-sensitive epithelial OC * Has provided tissue of a tumor lesion that was not previously irradiated * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2) * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2) Exclusion Criteria: * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma * Has platinum-resistant OC or platinum-refractory OC * Has 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 (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received more than 2 prior lines of systemic therapy for OC * Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2) * Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids * Has an additional malignancy that is progressing or has required active treatment within the past 3 years * Has active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Has active or ongoing stomatitis

Study locations (30)

University of Alabama at Birmingham ( Site 0006)

Birmingham, Alabama, 35249

Recruiting
Study Coordinator · Contact

Alaska Women's Cancer Care ( Site 0096)

Anchorage, Alaska, 99508

Recruiting
Study Coordinator · Contact

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)

New Haven, Connecticut, 06510

Recruiting
Study Coordinator · Contact

Mount Sinai Cancer Center ( Site 0078)

Miami Beach, Florida, 33140

Recruiting
Study Coordinator · Contact

Sarasota Memorial Hospital ( Site 0075)

Sarasota, Florida, 34239

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 0086)

Atlanta, Georgia, 30322

Recruiting
Study Coordinator · Contact

Augusta University - Georgia Cancer Center ( Site 0066)

Augusta, Georgia, 30912

Recruiting
Study Coordinator · Contact

Parkview Research Center at Parkview Regional Medical Center ( Site 0003)

Fort Wayne, Indiana, 46845

Recruiting
Study Coordinator · Contact

Women's Cancer Care ( Site 0067)

Covington, Louisiana, 70433

Recruiting
Study Coordinator · Contact

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)

Scarborough, Maine, 04074

Recruiting
Study Coordinator · Contact

St. Dominic's Hospital ( Site 0064)

Jackson, Mississippi, 39216

Active Not Recruiting

Nebraska Methodist Hospital ( Site 0053)

Omaha, Nebraska, 68114

Recruiting
Study Coordinator · Contact

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)

Hackensack, New Jersey, 07601

Recruiting
Study Coordinator · Contact

Rutgers Cancer Institute of New Jersey ( Site 0071)

New Brunswick, New Jersey, 08901

Recruiting
Study Coordinator · Contact

University of New Mexico Comprehensive Cancer Center ( Site 0055)

Albuquerque, New Mexico, 87131

Recruiting
Study Coordinator · Contact

NYU Langone Hospital - Long Island ( Site 0015)

Mineola, New York, 11501

Recruiting
Study Coordinator · Contact

Laura and Isaac Perlmutter Cancer Center ( Site 0076)

New York, New York, 10016

Recruiting
Study Coordinator · Contact

FirstHealth Cancer Center ( Site 0079)

Pinehurst, North Carolina, 28374

Recruiting
Study Coordinator · Contact

University of Cincinnati Medical Center ( Site 0090)

Cincinnati, Ohio, 45219

Recruiting
Study Coordinator · Contact

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)

Columbus, Ohio, 43210

Recruiting
Study Coordinator · Contact

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)

Tulsa, Oklahoma, 74146

Recruiting
Study Coordinator · Contact

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)

Eugene, Oregon, 97401

Recruiting
Study Coordinator · Contact

Women & Infants Hospital ( Site 0050)

Providence, Rhode Island, 02905

Recruiting
Study Coordinator · Contact

Henry-Joyce Cancer Clinic ( Site 0060)

Nashville, Tennessee, 37232

Recruiting
Study Coordinator · Contact

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas, 78758

Recruiting
Study Coordinator · Contact

Texas Oncology - DFW ( Site 8001)

Fort Worth, Texas, 76104

Recruiting
Study Coordinator · Contact

Texas Oncology - San Antonio ( Site 8005)

San Antonio, Texas, 78240

Recruiting
Study Coordinator · Contact

Texas Oncology - Gulf Coast ( Site 8003)

Webster, Texas, 77598

Recruiting
Study Coordinator · Contact

Virginia Cancer Specialists (VCS) ( Site 8011)

Fairfax, Virginia, 22031

Recruiting
Study Coordinator · Contact