A Clinical Trial of Sacituzumab Tirumotecan in People With Ovarian Cancer (MK-2870-021)

NCT ID: NCT07318558

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-25
• Study Completion Date: 2033-05-20

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sacituzumab tirumotecan

Intervention Type: DRUG

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

Bevacizumab

Intervention Type: DRUG

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

Rescue Medications

Intervention Type: DRUG

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. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

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.

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

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

Interventions

Sacituzumab tirumotecan

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

Intervention Type: DRUG

Bevacizumab

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

Intervention Type: DRUG

Rescue Medications

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. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

Intervention Type: DRUG

Other Intervention Names

sac-TMT; MK-2870; SKB264; Avastin; Altuzan; MVASI

Eligibility Criteria

Inclusion Criteria

• Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
• 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, or complete response per protocol.
• Has provided tumor tissue that is not previously irradiated.
• If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.
• 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.

Exclusion Criteria

• Has nonepithelial cancers, 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, or has current pneumonitis/ILD.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-2870-021

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-3102

Identifier Type: OTHER

Identifier Source: secondary_id

ENGOT-ov85

Identifier Type: OTHER

Identifier Source: secondary_id

2870-021

Identifier Type: -

Identifier Source: org_study_id