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A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)
Primary:
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time Frame: Up to approximately 38 months]
Overall Survival (OS) [Time Frame: Up to approximately 46 months]
Secondary:
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24
Overall Survival (OS) at Month 36
Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progression-Free Survival (PFS) Per RECIST 1.1 in Programmed Cell Death 1 Ligand (PD-L1) Positive Participants
Overall Survival in PD-L1 Positive Participants
Progression-Free Survival After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment
Change from Baseline in EORTC QLQ-C30 Global Health Status Score
Change from Baseline in EORTC QLQ-C30 Physical Function Score
Change from Baseline EORTC QLQ-CX24 Score
Number of Participants Who Experience One or More Adverse Events
Number of Participants Who Discontinue Study Treatment Due to and Adverse Event
Primary:
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time Frame: Up to approximately 38 months]
Overall Survival (OS) [Time Frame: Up to approximately 46 months]
Secondary:
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24
Overall Survival (OS) at Month 36
Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progression-Free Survival (PFS) Per RECIST 1.1 in Programmed Cell Death 1 Ligand (PD-L1) Positive Participants
Overall Survival in PD-L1 Positive Participants
Progression-Free Survival After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment
Change from Baseline in EORTC QLQ-C30 Global Health Status Score
Change from Baseline in EORTC QLQ-C30 Physical Function Score
Change from Baseline EORTC QLQ-CX24 Score
Number of Participants Who Experience One or More Adverse Events
Number of Participants Who Discontinue Study Treatment Due to and Adverse Event
Recruitment Status
Past Studies