A Clinical Trial of Sacituzumab Tirumotecan for Advanced Ovarian Cancer

This study is looking for new ways to treat advanced ovarian cancer. Researchers are testing sacituzumab tirumotecan (sac-TMT), a targeted therapy, alongside bevacizumab, another targeted therapy often used as maintenance treatment after chemotherapy. The study aims to see if this combination can stop the cancer from growing or spreading for longer (called Progression-Free Survival or PFS). You may be able to join if you are a woman, 18 or older, with advanced ovarian, primary peritoneal, or fallopian tube cancer that is high-grade serous, high-grade endometrioid, clear cell, or malignant mixed Müllerian with a high-grade serous component. About 900 people are expected to participate, but the study's current status is unclear.

Study design
This interventional study plans to enroll 900 participants. The phase of the study is not specified.
What's involved
Participants will receive sacituzumab tirumotecan and bevacizumab through IV infusions. You will also receive prophylactic steroid mouthwash and recommended rescue medications before sac-TMT infusions.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured for up to approximately 49 months.

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NCT07318558

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~900 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanBevacizumabRescue Medications

At a glance

Recruiting sites
159 of 159 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to approximately 49 months
Ovarian Neoplasms
Ovarian Cancer
159 sites across 111 states
Italy7
Spain7
Japan5
Taiwan5
Czechia4
Tennessee3
Buenos Aires3
Quebec3
  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
  • Progression-Free Survival (PFS)Up to approximately 49 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.