A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

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

Age range

18+ years

Sex

Female

Healthy volunteers

No

Interventions

• Biological
  Sacituzumab Tirumotecan

  IV infusion

• Drug
  Pemetrexed

  IV infusion

• Biological
  Tisotumab Vedotin

  IV infusion

• Drug
  Topotecan

  IV infusion

• Drug
  Vinorelbine

  IV infusion

• Drug
  Gemcitabine

  IV infusion

• Drug
  Irinotecan

  IV infusion

Locations (240)