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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Part 1: Number of Participants With One or More Adverse Events (AEs) — Up to 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. - Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE — Up to 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. - Part 2: Progression-Free Survival (PFS) — Up to approximately 4 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Trial sites (197)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| The University of Kansas Cancer Center - Westwood ( Site 0002) | Westwood | Kansas | 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 |
+ 157 more sites — see the full list on the official registry below.
On this site
📄 Avastin (bevacizumab) drug profile →More Merck Sharp & Dohme LLC trials in Spain
Other trials for the same condition
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 Spain