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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 686
Last updated 2026-05-22
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.
Conditions
Interventions
- BIOLOGICAL
-
IV infusion
- DRUG
-
Pemetrexed
IV infusion
- BIOLOGICAL
-
Tisotumab Vedotin
IV infusion
- DRUG
-
Topotecan
IV infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
Sponsors & Collaborators
-
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER -
GOG Foundation
collaborator NETWORK - lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-24
- Primary Completion
- 2028-06-15
- Completion
- 2028-06-15
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Denmark
- Finland
- France
- Germany
- Greece
- Ireland
- Israel
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- Norway
- Poland
- Puerto Rico
- Singapore
- South Korea
- Spain
- Sweden
- Switzerland
- United Kingdom
Study Locations
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