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Clinical Trials in the UK / NCT06459180
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 UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2024-07-24
Last updated
2026-08-28

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Sacituzumab TirumotecanPemetrexedTisotumab VedotinTopotecanVinorelbineGemcitabineIrinotecan

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)

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.

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

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 the UK