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

RecruitingPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Who can join

Ages 18 and older · Women

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 900 · Started: Feb 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07318558

Locations in the U.S.

AlabamaUniversity of Alabama - Birmingham ( Site 0058), Birmingham
CaliforniaJohn Muir Health Cancer Center ( Site 0069), Walnut Creek
FloridaMount Sinai Cancer Center ( Site 0029), Miami Beach
Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085), Orlando
GeorgiaWinship Cancer Institute of Emory University ( Site 0037), Atlanta
IllinoisIllinois Cancer Specialists (ICS) ( Site 8009), Arlington Heights
IndianaParkview Research Center at Parkview Regional Medical Center ( Site 0055), Fort Wayne
Franciscan Health Indianapolis ( Site 0081), Indianapolis
LouisianaWomen's Cancer Care ( Site 0018), Covington
MaineMaine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060), Scarborough
MarylandMaryland Oncology Hematology (MOH) ( Site 8002), Columbia
NebraskaNebraska Methodist Hospital ( Site 0004), Omaha
University Of Nebraska Medical Center ( Site 0035), Omaha
NevadaThe Center of Hope ( Site 0025), Reno
New YorkWomens Cancer Care Associates, LLC ( Site 0023), Albany
Memorial Sloan Kettering Cancer Center ( Site 0072), New York
North CarolinaDuke Cancer Center ( Site 0012), Durham
OhioUniversity of Cincinnati Medical Center ( Site 0042), Cincinnati
OklahomaOklahoma Cancer Specialists and Research Institute, LLC ( Site 0007), Tulsa
PennsylvaniaHospital of the University of Pennsylvania ( Site 0071), Philadelphia
Rhode IslandWomen & Infants Hospital ( Site 0001), Providence
TennesseeWest Cancer Center and Research Institute ( Site 0013), Germantown
University of Tennessee Medical Center ( Site 0087), Knoxville
Henry-Joyce Cancer Clinic ( Site 0011), Nashville
VirginiaVirginia Cancer Specialists (VCS) ( Site 8012), Fairfax
Virginia Oncology Associates (VOA) ( Site 8013), Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.