Recruiting
Phase 3

Sac-TMT & Bevacizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07318558

Conditions

Ovarian Neoplasms

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Bevacizumab

Rescue Medications

Study Details

Brief summary:

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:

  • Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
  • Observation, which is watching to see if cancer grows or worsens

The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Conditions

Ovarian Neoplasms

Ovarian Cancer

Study ID

NCT07318558

Start date

Feb 16, 2026

Status verified date

Sep, 2026

Completion date

Feb 25, 2033

Anticipated

Primary completion date

Feb 25, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

The main inclusion criteria include but are not limited to the following:

  • Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present.
  • Has completed primary debulking surgery or interval debulking surgery.
  • Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
  • Has provided tumor tissue that is not previously irradiated.
  • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
  • Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
  • Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.

The main exclusion criteria include but are not limited to the following:

  • Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has a history of severe eye disease.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
  • Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.
  • Had a live or live-attenuated vaccine within 30 days of randomization.
  • Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
  • Has active infection requiring systemic therapy.
  • Has concurrent and active HBV and HCV infections.
  • Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
  • Has not recovered from major surgery or has ongoing surgical complications.
  • Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
  • Active or ongoing stomatitis of any grade.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sac-TMT +/- Bevacizumab

Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.

active comparator: Standard of Care

Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.

Interventions

Sacituzumab tirumotecan

Administered via intravenous (IV) infusion at a dose of 4mg/kg

Bevacizumab

Administered via IV infusion at a dose of 15mg/kg

Rescue Medications

Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants 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.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: Up to approximately 49 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

University of Alabama - Birmingham ( Site 0058)

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Study Coordinator

205-934-4986

John Muir Health Cancer Center ( Site 0069)

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Study Coordinator

925-692-5603

Mount Sinai Cancer Center ( Site 0029)

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Study Coordinator

305-674-2625

Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

321-841-8393

Winship Cancer Institute of Emory University ( Site 0037)

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Study Coordinator

404-778-1900

Illinois Cancer Specialists (ICS) ( Site 8009)

Recruiting

Arlington Heights, Illinois, United States, 60005

Contacts

Study Coordinator

847-259-4482

Parkview Research Center at Parkview Regional Medical Center ( Site 0055)

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Study Coordinator

206-266-7701

Franciscan Health Indianapolis ( Site 0081)

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Study Coordinator

317-528-5000

Women's Cancer Care ( Site 0018)

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Study Coordinator

985-892-2252

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Study Coordinator

207-883-0069

Maryland Oncology Hematology, P.A. ( Site 8002)

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Study Coordinator

410-964-2212

Nebraska Methodist Hospital ( Site 0004)

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Study Coordinator

402-354-7939

University Of Nebraska Medical Center ( Site 0035)

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Study Coordinator

402-559-2000

The Center of Hope ( Site 0025)

Recruiting

Reno, Nevada, United States, 89511

Contacts

Study Coordinator

775-327-4673

Womens Cancer Care Associates, LLC ( Site 0023)

Recruiting

Albany, New York, United States, 12208-1743

Contacts

Study Coordinator

518-458-1390

Memorial Sloan Kettering Cancer Center ( Site 0072)

Recruiting

New York, New York, United States, 10022

Contacts

Study Coordinator

347-923-8746

Duke Cancer Center ( Site 0012)

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Study Coordinator

919-681-6900

University of Cincinnati Medical Center ( Site 0042)

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Study Coordinator

513-584-1000

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Study Coordinator

918-505-3200

Hospital of the University of Pennsylvania ( Site 0071)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-662-4000

Women & Infants Hospital ( Site 0001)

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Study Coordinator

401-274-1122x48181

West Cancer Center and Research Institute ( Site 0013)

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Study Coordinator

901-683-0055

University of Tennessee Medical Center ( Site 0087)

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Study Coordinator

865-305-9000

Henry-Joyce Cancer Clinic ( Site 0011)

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Coordinator

615-936-4585

Virginia Cancer Specialists (VCS) ( Site 8012)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

703-280-5390

Virginia Oncology Associates (VOA) ( Site 8013)

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Study Coordinator

757-466-8663

CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

Contacts

Study Coordinator

418 541-1000

Centre Hospitalier de l'Université de Montréal ( Site 0518)

Recruiting

Montreal, Quebec, Canada, H2X 3H8

Contacts

Study Coordinator

514-890-8000

McGill University Health Centre ( Site 0516)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

514-934-1934 x31975

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 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.