A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
Condition(s) studied
Investigational drug(s) / intervention(s)
Sacituzumab Tirumotecan: IV infusion
Pemetrexed: IV infusion
Tisotumab Vedotin: IV infusion
Topotecan: IV infusion
Vinorelbine: IV infusion
Gemcitabine: IV infusion
Irinotecan: IV infusion
Study summary
This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.
The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in — Up to approximately 46 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. - Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in — Up to approximately 46 months
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. - Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in — Up to approximately 46 months
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. - Overall Survival (OS) in Phase 3 Portion — Up to approximately 35 months
OS is defined as the time from randomization to death due to any cause.
Trial sites (240)
| Facility | City | Region | Status |
|---|---|---|---|
| USA Mitchell Cancer Institute-Clinical Trials ( Site 4126) | Mobile | Alabama | |
| Providence Alaska Medical Center ( Site 4137) | Anchorage | Alaska | |
| HonorHealth (HH) ( Site 8002) | Phoenix | Arizona | |
| Arizona Oncology Associates - HOPE ( Site 8001) | Tucson | Arizona | |
| Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125) | La Jolla | California | |
| UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105) | Los Angeles | California | |
| Hoag Memorial Hospital Presbyterian ( Site 4104) | Newport Beach | California | |
| Mount Sinai Comprehensive Cancer Center ( Site 4143) | Miami Beach | Florida | |
| Advent Health ( Site 4140) | Orlando | Florida | |
| Florida Cancer Specialists East ( Site 7001) | West Palm Beach | Florida | |
| Northside Hospital ( Site 4127) | Atlanta | Georgia | |
| Georgia Cancer Center at Augusta University ( Site 4112) | Augusta | Georgia | |
| Lewis Cancer and Research Pavilion ( Site 4114) | Savannah | Georgia | |
| University Medical Center New Orleans ( Site 4132) | New Orleans | Louisiana | |
| Willis Knighton Medical Center ( Site 4101) | Shreveport | Louisiana | |
| The Center of Hope ( Site 4106) | Reno | Nevada | |
| Holy Name Medical Center ( Site 4117) | Teaneck | New Jersey | |
| Optimum Clinical Research Group ( Site 4138) | Albuquerque | New Mexico | |
| Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145) | Mineola | New York | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121) | New York | New York | |
| Duke Cancer Institute ( Site 4120) | Durham | North Carolina | |
| University of Cincinnati Medical Center ( Site 4128) | Cincinnati | Ohio | |
| The Ohio State University ( Site 4103) | Hilliard | Ohio | |
| Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116) | Tulsa | Oklahoma | |
| Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007) | Eugene | Oregon | |
| Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115) | Portland | Oregon | |
| Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142) | Philadelphia | Pennsylvania | |
| Asplundh Cancer Pavilion ( Site 4113) | Willow Grove | Pennsylvania | |
| The West Clinic, PLLC dba West Cancer Center ( Site 4108) | Germantown | Tennessee | |
| Texas Oncology - Central/South Texas ( Site 8010) | Austin | Texas | |
| Texas Oncology - DFW ( Site 8003) | Fort Worth | Texas | |
| Houston Methodist Hospital OB/GYN ( Site 4102) | Houston | Texas | |
| Texas Oncology - San Antonio ( Site 8006) | San Antonio | Texas | |
| Texas Oncology - Northeast Texas ( Site 8009) | Tyler | Texas | |
| Texas Oncology - Gulf Coast ( Site 8008) | Webster | Texas | |
| University of Virginia Cancer Center ( Site 4123) | Charlottesville | Virginia | |
| Inova Schar Cancer Institute ( Site 4139) | Fairfax | Virginia | |
| Swedish Medical Center-Swedish Cancer Institute ( Site 4134) | Seattle | Washington | |
| Hospital Británico de Buenos Aires-Oncology ( Site 0102) | Ciudad Autónoma de Buenos Aires | Buenos Aires | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107) | Mar del Plata | Buenos Aires |
+ 200 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in South Korea
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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 NCT06459180 on ClinicalTrials.gov ↗ ← All trials in South Korea