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Clinical Trials in the UK / NCT07318558
Recruiting Phase 3

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

NCT07318558 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-02-16
Last updated
2026-09-11

Condition(s) studied

Ovarian NeoplasmsOvarian Cancer

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecanBevacizumabRescue Medications

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (162)

FacilityCityRegionStatus
University of Alabama - Birmingham ( Site 0058) Birmingham Alabama Recruiting
John Muir Health Cancer Center ( Site 0069) Walnut Creek California Recruiting
Mount Sinai Cancer Center ( Site 0029) Miami Beach Florida Recruiting
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085) Orlando Florida Recruiting
Winship Cancer Institute of Emory University ( Site 0037) Atlanta Georgia Recruiting
Illinois Cancer Specialists (ICS) ( Site 8009) Arlington Heights Illinois Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0055) Fort Wayne Indiana Recruiting
Franciscan Health Indianapolis ( Site 0081) Indianapolis Indiana Recruiting
Women's Cancer Care ( Site 0018) Covington Louisiana Recruiting
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060) Scarborough Maine Recruiting
Maryland Oncology Hematology, P.A. ( Site 8002) Columbia Maryland Recruiting
Nebraska Methodist Hospital ( Site 0004) Omaha Nebraska Recruiting
University Of Nebraska Medical Center ( Site 0035) Omaha Nebraska Recruiting
The Center of Hope ( Site 0025) Reno Nevada Recruiting
Womens Cancer Care Associates, LLC ( Site 0023) Albany New York Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0072) New York New York Recruiting
Duke Cancer Center ( Site 0012) Durham North Carolina Recruiting
University of Cincinnati Medical Center ( Site 0042) Cincinnati Ohio Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007) Tulsa Oklahoma Recruiting
Hospital of the University of Pennsylvania ( Site 0071) Philadelphia Pennsylvania Recruiting
Women & Infants Hospital ( Site 0001) Providence Rhode Island Recruiting
West Cancer Center and Research Institute ( Site 0013) Germantown Tennessee Recruiting
University of Tennessee Medical Center ( Site 0087) Knoxville Tennessee Recruiting
Henry-Joyce Cancer Clinic ( Site 0011) Nashville Tennessee Recruiting
Virginia Cancer Specialists (VCS) ( Site 8012) Fairfax Virginia Recruiting
Virginia Oncology Associates (VOA) ( Site 8013) Norfolk Virginia Recruiting
Hospital Aleman ( Site 2903) Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Instituto Alexander Fleming ( Site 2902) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901) Mar del Plata Buenos Aires Recruiting
Fundación Respirar ( Site 2912) Buenos Aires Buenos Aires F.D. Recruiting
Sanatorio Parque - Oncología ( Site 2911) Rosario Santa Fe Province Recruiting
Instituto de Oncologia de Rosario ( Site 2909) Rosario Santa Fe Province Recruiting
Hospital Britanico de Buenos Aires ( Site 2905) CABA Argentina Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907) La Rioja Argentina Recruiting
Westmead Hospital ( Site 0201) Westmead New South Wales Recruiting
Gallipoli Medical Research Ltd ( Site 0204) Brisbane Queensland Recruiting
Epworth Freemasons ( Site 0207) East Melbourne Victoria Recruiting
Medizinische Universitat Wien ( Site 0102) Vienna State of Vienna Recruiting
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101) Innsbruck Tyrol Recruiting
Grand Hopital de Charleroi ( Site 0303) Charleroi Hainaut Recruiting

+ 122 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07318558 on ClinicalTrials.gov ↗ ← All trials in the UK