Sacituzumab Tirumotecan for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Eligibility Criteria

This trial is for individuals with platinum-sensitive recurrent ovarian cancer who've had specific chemotherapy treatments. They must have confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and provide a tumor tissue sample. Participants with well-controlled HIV, hepatitis B or C are eligible if they meet certain conditions.

Inclusion Criteria

My cancer is confirmed in the ovary, fallopian tube, or peritoneum.

I've had 4+ cycles of first-line and 6 cycles of second-line platinum-based chemo for ovarian cancer.

My ovarian cancer responds well to platinum-based chemotherapy.

I have provided a sample from a tumor that hasn't been treated with radiation.

I have hepatitis B but have been on antiviral therapy for over 4 weeks with an undetectable viral load.

Participant Groups

The study tests the safety and effectiveness of Sacituzumab Tirumotecan alone or combined with Bevacizumab versus standard care. It aims to see if these treatments can extend the time patients live without their cancer worsening compared to current treatments.

3Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: Sacituzumab tirumotecanExperimental Treatment7 Interventions

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Group II: Part 1: Sacituzumab tirumotecan + BevacizumabExperimental Treatment7 Interventions

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks

Group III: Part 2: Standard of care (SOC)Active Control1 Intervention

Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.