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Clinical Trials in the UK / NCT06824467
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2025-04-09
Last updated
2026-09-03

Condition(s) studied

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecanBevacizumabH1 receptor antagonistH2 receptor antagonistAcetaminophen (or equivalent)Dexamethasone (or equivalent)Steroid mouthwash (dexamethasone or equivalent)

Sacituzumab tirumotecan: IV Infusion

Bevacizumab: IV Infusion

H1 receptor antagonist: Rescue medication taken per approved product label before sacituzumab tirumotecan

H2 receptor antagonist: Rescue medication taken per approved product label before sacituzumab tirumotecan

Acetaminophen (or equivalent): Rescue medication taken per approved product label before sacituzumab tirumotecan

Dexamethasone (or equivalent): Rescue medication taken per approved product label before sacituzumab tirumotecan

Steroid mouthwash (dexamethasone or equivalent): Rescue medication taken orally 2-4 times daily

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) * Has platinum-sensitive epithelial OC * Has provided tissue of a tumor lesion that was not previously irradiated * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2) * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2) Exclusion Criteria: * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma * Has platinum-resistant OC or platinum-refractory OC * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received more than 2 prior lines of systemic therapy for OC * Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2) * Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids * Has an additional malignancy that is progressing or has required active treatment within the past 3 years * Has active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Has active or ongoing stomatitis

Primary outcome measure(s)

Trial sites (196)

FacilityCityRegionStatus
University of Alabama at Birmingham ( Site 0006) Birmingham Alabama Recruiting
Alaska Women's Cancer Care ( Site 0096) Anchorage Alaska Recruiting
UCSF Medical Center at Mission Bay ( Site 0013) San Francisco California Recruiting
John Muir Health Cancer Center ( Site 0016) Walnut Creek California Recruiting
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001) New Haven Connecticut Recruiting
Mount Sinai Braman Comprehensive Cancer Center ( Site 0078) Miami Beach Florida Recruiting
Sarasota Memorial Hospital ( Site 0075) Sarasota Florida Recruiting
Florida Cancer Specialists East ( Site 7000) West Palm Beach Florida Recruiting
Winship Cancer Institute of Emory University ( Site 0086) Atlanta Georgia Recruiting
Augusta University - Georgia Cancer Center ( Site 0066) Augusta Georgia Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0003) Fort Wayne Indiana Recruiting
Women's Cancer Care ( Site 0067) Covington Louisiana Recruiting
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008) Scarborough Maine Recruiting
Minnesota Oncology Hematology (MNO) ( Site 8002) Maplewood Minnesota Recruiting
St. Dominic's Hospital ( Site 0064) Jackson Mississippi Active Not Recruiting
Washington University School of Medicine ( Site 0052) St Louis Missouri Recruiting
Nebraska Methodist Hospital ( Site 0053) Omaha Nebraska Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081) Hackensack New Jersey Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0071) New Brunswick New Jersey Recruiting
University of New Mexico Comprehensive Cancer Center ( Site 0055) Albuquerque New Mexico Recruiting
NYU Langone Hospital - Long Island ( Site 0015) Mineola New York Recruiting
Laura and Isaac Perlmutter Cancer Center ( Site 0076) New York New York Recruiting
FirstHealth Cancer Center ( Site 0079) Pinehurst North Carolina Recruiting
University of Cincinnati Medical Center ( Site 0090) Cincinnati Ohio Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054) Columbus Ohio Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056) Tulsa Oklahoma Recruiting
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010) Eugene Oregon Recruiting
Allegheny Health Network West Penn Hospital ( Site 0099) Pittsburgh Pennsylvania Recruiting
Women & Infants Hospital ( Site 0050) Providence Rhode Island Recruiting
Henry-Joyce Cancer Clinic ( Site 0060) Nashville Tennessee Recruiting
Texas Oncology - Central/South Texas ( Site 8009) Austin Texas Recruiting
Texas Oncology - DFW ( Site 8001) Fort Worth Texas Recruiting
University Of Texas Health Science Center -San Antonio ( Site 0095) San Antonio Texas Recruiting
Texas Oncology - San Antonio ( Site 8005) San Antonio Texas Recruiting
Texas Oncology - Gulf Coast ( Site 8003) Webster Texas Recruiting
Virginia Cancer Specialists (VCS) ( Site 8011) Fairfax Virginia Recruiting
Instituto Alexander Fleming ( Site 2909) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901) Mar del Plata Buenos Aires Recruiting
Fundación Respirar ( Site 2912) Buenos Aires Buenos Aires F.D. Recruiting
Instituto de Oncologia de Rosario ( Site 2910) Rosario Santa Fe Province Recruiting

+ 156 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06824467 on ClinicalTrials.gov ↗ ← All trials in the UK