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)

Running, not enrolling · Phase 3

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT06459180

Run by

Merck Sharp & Dohme LLC

People needed

686

Starts

2024-07-24

Expected to finish

2028-06-15

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence Alaska Medical Center ( Site 4137) — Anchorage, Alaska, United States
• HonorHealth (HH) ( Site 8002) — Phoenix, Arizona, United States
• Arizona Oncology Associates - HOPE ( Site 8001) — Tucson, Arizona, United States
• Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125) — La Jolla, California, United States
• UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105) — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian ( Site 4104) — Newport Beach, California, United States
• Mount Sinai Braman Comprehensive Cancer Center ( Site 4143) — Miami Beach, Florida, United States
• Advent Health ( Site 4140) — Orlando, Florida, United States
• Florida Cancer Specialists East ( Site 7001) — West Palm Beach, Florida, United States
• Northside Hospital ( Site 4127) — Atlanta, Georgia, United States
• Georgia Cancer Center at Augusta University ( Site 4112) — Augusta, Georgia, United States
• Lewis Cancer and Research Pavilion ( Site 4114) — Savannah, Georgia, United States
• University Medical Center New Orleans ( Site 4132) — New Orleans, Louisiana, United States
• Willis Knighton Medical Center ( Site 4101) — Shreveport, Louisiana, United States
• The Center of Hope ( Site 4106) — Reno, Nevada, United States
• Holy Name Medical Center ( Site 4117) — Teaneck, New Jersey, United States
• Optimum Clinical Research Group ( Site 4138) — Albuquerque, New Mexico, United States
• Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145) — Mineola, New York, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121) — New York, New York, United States
• Duke Cancer Institute ( Site 4120) — Durham, North Carolina, United States
• University of Cincinnati Medical Center ( Site 4128) — Cincinnati, Ohio, United States
• The Ohio State University ( Site 4103) — Hilliard, Ohio, United States
• Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116) — Tulsa, Oklahoma, United States
• Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007) — Eugene, Oregon, United States
• USA Mitchell Cancer Institute-Clinical Trials ( Site 4126) — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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