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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)

RecruitingPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

Who can join

Ages 18 and older · Women

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 770 · Started: Apr 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06824467

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham ( Site 0006), Birmingham
AlaskaAlaska Women's Cancer Care ( Site 0096), Anchorage
CaliforniaUCSF Medical Center at Mission Bay ( Site 0013), San Francisco
John Muir Health Cancer Center ( Site 0016), Walnut Creek
ConnecticutYale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001), New Haven
FloridaMount Sinai Braman Comprehensive Cancer Center ( Site 0078), Miami Beach
Sarasota Memorial Hospital ( Site 0075), Sarasota
Florida Cancer Specialists East ( Site 7000), West Palm Beach
GeorgiaWinship Cancer Institute of Emory University ( Site 0086), Atlanta
Augusta University - Georgia Cancer Center ( Site 0066), Augusta
IndianaParkview Research Center at Parkview Regional Medical Center ( Site 0003), Fort Wayne
LouisianaWomen's Cancer Care ( Site 0067), Covington
MaineMaine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008), Scarborough
MinnesotaMinnesota Oncology Hematology (MNO) ( Site 8002), Maplewood
MissouriWashington University School of Medicine ( Site 0052), St Louis
NebraskaNebraska Methodist Hospital ( Site 0053), Omaha
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0081), Hackensack
Rutgers Cancer Institute of New Jersey ( Site 0071), New Brunswick
New MexicoUniversity of New Mexico Comprehensive Cancer Center ( Site 0055), Albuquerque
New YorkNYU Langone Hospital - Long Island ( Site 0015), Mineola
Laura and Isaac Perlmutter Cancer Center ( Site 0076), New York
North CarolinaFirstHealth Cancer Center ( Site 0079), Pinehurst
OhioUniversity of Cincinnati Medical Center ( Site 0090), Cincinnati
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054), Columbus
OklahomaOklahoma Cancer Specialists and Research Institute, LLC ( Site 0056), Tulsa
OregonOncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010), Eugene
PennsylvaniaAllegheny Health Network West Penn Hospital ( Site 0099), Pittsburgh
Rhode IslandWomen & Infants Hospital ( Site 0050), Providence
TennesseeHenry-Joyce Cancer Clinic ( Site 0060), Nashville
TexasTexas Oncology - Central/South Texas ( Site 8009), Austin
Texas Oncology - DFW ( Site 8001), Fort Worth
Texas Oncology - San Antonio ( Site 8005), San Antonio
University Of Texas Health Science Center -San Antonio ( Site 0095), San Antonio
Texas Oncology - Gulf Coast ( Site 8003), Webster
VirginiaVirginia Cancer Specialists (VCS) ( Site 8011), Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.