770 Participants Needed

Sacituzumab Tirumotecan for Ovarian Cancer

Recruiting at 26 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Antiretrovirals, HBV antivirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Research Team

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

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

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 HIV and it is well controlled with medication.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan with or without bevacizumab or standard of care treatment

6 weeks
Every 2-3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years

Treatment Details

Interventions

  • Bevacizumab
  • Sacituzumab Tirumotecan
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

GOG Foundation

Collaborator

Trials
48
Recruited
18,500+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials
41
Recruited
19,200+
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