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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)

NCT06824467 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Steroid mouthwash (dexamethasone or equivalent)

Rescue medication taken orally 2-4 times daily

BIOLOGICAL

Sacituzumab tirumotecan

IV Infusion

BIOLOGICAL

Bevacizumab

IV Infusion

DRUG

H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • GOG Foundation

    collaborator NETWORK

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2029-04-27
Completion
2032-11-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Portugal
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06824467 on ClinicalTrials.gov