drugset
drugset / Trial / NCT06459180

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 ↗

Phase 3 Active not recruiting 686 enrolled Merck Sharp & Dohme LLC European Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-24
Primary completion
2028-06-15
Completion
2028-06-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Irinotecan Small molecule 100 mg/m2 Intravenous
Comparator Irinotecan Small molecule 125 mg/m2 Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous
Comparator Tisotumab Vedotin Other / unclassified 2 mg/kg Intravenous
Comparator Topotecan Small molecule 1 mg/m2 Intravenous
Comparator Topotecan Small molecule 1.25 mg/m2 Intravenous
Comparator Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications

cervical cancer