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)

Condition studied

Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs), Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review, Part 2 Maintenance Treatment: Overall Survival (OS)

Endpoint detail

Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator, Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs, Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE, Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score, Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score