Recruiting

Phase 3

Sacituzumab Tirumotecan vs. Standard of CareA Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06824467

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Bevacizumab

H1 receptor antagonist

H2 receptor antagonist

Acetaminophen (or equivalent)

Study Details

Brief 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.

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer

Study ID

NCT06824467

Start date

Apr 9, 2025

Status verified date

Sep, 2026

Completion date

Nov 9, 2032

Anticipated

Primary completion date

Apr 27, 2029

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has locally advanced or metastatic, histologically confirmed 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 to 8 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, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening
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 Design

Enrollment

770 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Sacituzumab tirumotecan + Bevacizumab

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks

experimental: Part 2: Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

active comparator: Part 2: Standard of care (SOC)

Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Interventions

Sacituzumab tirumotecan

IV Infusion

Bevacizumab

IV Infusion

H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

Steroid mouthwash (dexamethasone or equivalent)

Rescue medication taken orally 2-4 times daily

Primary outcome measure

Part 1: Number of Participants With One or More Adverse Events (AEs) [ Time Frame: Up to 6 weeks ]
Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to 6 weeks ]
Part 2: Progression-Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

University of Alabama at Birmingham ( Site 0006)

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Study Coordinator

(205) 934-7442

Alaska Women's Cancer Care ( Site 0096)

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Study Coordinator

907-562-4673

UCSF Medical Center at Mission Bay ( Site 0013)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

415-353-3000

John Muir Health Cancer Center ( Site 0016)

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Study Coordinator

925-692-5603

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

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

203-785-5702

Mount Sinai Braman Comprehensive Cancer Center ( Site 0078)

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Study Coordinator

305-674-2625

Sarasota Memorial Hospital ( Site 0075)

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Study Coordinator

941-917-2225

Florida Cancer Specialists East ( Site 7000)

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Study Coordinator

561-366-4100

Winship Cancer Institute of Emory University ( Site 0086)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Study Coordinator

404-778-1900

Augusta University - Georgia Cancer Center ( Site 0066)

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Study Coordinator

706-721-6744

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

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Study Coordinator

260-425-6981

Women's Cancer Care ( Site 0067)

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Study Coordinator

985-892-2252

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

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Study Coordinator

207-883-0069

Minnesota Oncology Hematology (MNO) ( Site 8002)

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Study Coordinator

615-693-2574

Washington University School of Medicine ( Site 0052)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-454-6215

Nebraska Methodist Hospital ( Site 0053)

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Study Coordinator

402-354-8534

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5855

Rutgers Cancer Institute of New Jersey ( Site 0071)

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Study Coordinator

732-235-7258

University of New Mexico Comprehensive Cancer Center ( Site 0055)

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Study Coordinator

505-272-4946

NYU Langone Hospital - Long Island ( Site 0015)

Recruiting

Mineola, New York, United States, 11501

Contacts

Study Coordinator

516-663-0333

Laura and Isaac Perlmutter Cancer Center ( Site 0076)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

212-731-6000

FirstHealth Cancer Center ( Site 0079)

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Study Coordinator

910-715-8684

University of Cincinnati Medical Center ( Site 0090)

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Study Coordinator

513-584-1958

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

614-293-3300

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

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Study Coordinator

918-505-3200

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

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Study Coordinator

541-683-5001

Allegheny Health Network West Penn Hospital ( Site 0099)

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Study Coordinator

412-578-5000

Women & Infants Hospital ( Site 0050)

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Study Coordinator

401-274-1100

Henry-Joyce Cancer Clinic ( Site 0060)

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Coordinator

615-936-8422

Texas Oncology - Central/South Texas ( Site 8009)

Recruiting

Austin, Texas, United States, 78758

Contacts

Study Coordinator

512-873-8900

Texas Oncology - DFW ( Site 8001)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-413-1500

University Of Texas Health Science Center -San Antonio ( Site 0095)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-567-7000

Texas Oncology - San Antonio ( Site 8005)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-595-5300

Texas Oncology - Gulf Coast ( Site 8003)

Recruiting

Webster, Texas, United States, 77598

Contacts

Study Coordinator

281-332-7505

Virginia Cancer Specialists (VCS) ( Site 8011)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

(571) 350-8400

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0512)

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Study Coordinator

5872315594

Health Sciences North Research Institute ( Site 0517)

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Study Coordinator

7055237100

Trillium Health Partners - Credit Valley Hospital ( Site 0508)

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Study Coordinator

905-813-2200

Princess Margaret Cancer Centre ( Site 0518)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

(416) 946-4501

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0505)

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Study Coordinator

514-252-3400

McGill University Health Centre ( Site 0502)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

514-934-1934

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.