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

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment this month; Phase 3

Conditions: Ovarian Neoplasms; Ovarian Cancer

Treatments: Drug: Sacituzumab tirumotecan; Drug: Rescue Medications; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07318558

ENGOT-ov85 (Other Identifier)

MK-2870-021 (Other Identifier)

2870-021

GOG-3102 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

• 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.

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

• 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Sac-TMT +/- Bevacizumab

Experimental group

Description:

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.

Treatment:

Drug: Bevacizumab

Drug: Rescue Medications

Drug: Sacituzumab tirumotecan

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Drug: Bevacizumab