Ireland
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Active, not recruiting Phase 3

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)

NCT06459180 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2024-07-24
Last updated
2026-08-28

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Sacituzumab Tirumotecan →Pemetrexed →Tisotumab Vedotin →Topotecan →Vinorelbine →Gemcitabine →Irinotecan →

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens * Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions * Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent * Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion * Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated * HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) 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 (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion) * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has adequate organ function Exclusion Criteria: * Has Grade ≥2 peripheral neuropathy * 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Received prior systemic anticancer therapy * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix. * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Concurrent active Hepatitis B and active Hepatitis C virus infection * Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy * Participants who have not adequately recovered from major surgery or have ongoing surgical complications * Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

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)

FacilityCityRegionStatus
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.

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 NCT06459180 on ClinicalTrials.gov ↗ ← All trials in South Korea