Clinical Trial

Title: A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

MOA: Sacituzumab tirumotecan (Sac-TMT) is a TROP2-targeted ADC with a topoisomerase I inhibitor payload.

Key Eligibility:

Part 2 induction: Screening

• Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma or
  adenocarcinoma of cervix
• Persistent/recurrent/newly diagnosed metastatic cervical cancer not amenable to
  curative tx
• PD-L1 CPS ≥1 per the central laboratory
• Measurable disease per RECIST 1.1
  before induction
• Prior tx with anti-PD-(L)1/2 or another stimulatory/coinhibitory T-cell receptor, anti
  TROP2 ADC, bispecific agents targeting PD-(L)1, any ADC for cervical cancer, or
  systemic anticancer tx excluded
  • Prior CRT or induction chemo prior to RT in LACC setting is allowed
    
• Part 2: Maintenance and Optional Subsequent Treatment
• Valid TROP2 result per the central laboratory before randomization
• Maintenance only:
  • Has completed 6 cycles of induction before randomization and achieved CR, PR, or
    SD per RECIST v1.1 by investigator
• Optional Subsequent Treatment:
  • BICR-verified PD per RECIST 1.1 during/after protocol-specified induction but before
    randomization to Maintenance