A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab tirumotecan — BIOLOGICAL
  IV Infusion
• Bevacizumab — BIOLOGICAL
  IV Infusion
• H1 receptor antagonist — DRUG
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• H2 receptor antagonist — DRUG
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Acetaminophen (or equivalent) — DRUG
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Dexamethasone (or equivalent) — DRUG
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Steroid mouthwash (dexamethasone or equivalent) — DRUG
  Rescue medication taken orally 2-4 times daily

Study Details

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.

Key Dates

First listed

Feb 13, 2025

Start date

Apr 9, 2025

Status verified

Jul 2026

Primary completion

Apr 27, 2029

Completion

Nov 9, 2032

Study Design

Enrollment

770 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Sacituzumab tirumotecan + Bevacizumab
  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
• Experimental: Part 2: Sacituzumab tirumotecan
  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.
• Active Comparator: Part 2: Standard of care (SOC)
  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.

Primary Outcome Measure

Part 1: Number of participants with one or more adverse events (AEs) [ Time Frame: Up to 6 weeks ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (33)

Find similar trials in Birmingham, AL

Related Studies

• Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
  Recruiting · M.D. Anderson Cancer Center · Miami, Florida
• Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
  Recruiting · Stanford University · Stanford, California
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
  PHASE1/PHASE2 · Recruiting · Michael McHale · San Diego, California