Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Official Title

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)

Summary:

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by the Investigator
• Overall Survival (OS)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) at Month 24 as Assessed by Blinded Independent Central Review (BICR)
• Overall Survival (OS) at Month 36
• Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1) at Week 12 as Assessed by the Investigator
• Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST 1.1) at Week 12 as Assessed by Blinded Independent Central Review (BICR)
• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by the Investigator
• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
• Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
• Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
• Progression-Free Survival (PFS) After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment
• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
• Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
• Number of Participants Who Experience One or More Adverse Events (AEs)
• Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

View this trial on ClinicalTrials.gov