Study S003355

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/GOG-3047)

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT04221945
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: COMPLETED
Enrollment: 1060
Start: 2020-05-12
Primary completion: 2025-01-07
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Uterine Cervical Neoplasms
Interventions: BIOLOGICAL:Pembrolizumab; DRUG:Placebo for pembrolizumab; DRUG:Cisplatin; RADIATION:External Beam Radiotherapy (EBRT); RADIATION:Brachytherapy
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:MK-3475-A18; OTHER:KEYNOTE-A18; OTHER:ENGOT-cx11; REGISTRY:205189; OTHER:GOG-3047; REGISTRY:2022-501972-25-00; REGISTRY:U1111-1282-6395; EUDRACT_NUMBER:2019-003152-37; NIH:2019

Registered primary outcomes

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator [Up to approximately 55 months]
Overall Survival (OS) [Up to approximately 55 months]

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