Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

Official Title

A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUSSTANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

Summary:

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumour activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

Trial Description

Primary Outcome:

• Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumours v1.1 (RECIST v1.1) as Assessed by Investigator

• Overall Survival (OS)
• Pathologic Complete Response (pCR) Rate in Participants With Salvage Surgery at the Primary Site
• Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator
• Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator
• Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator
• Duration of Response (DOR) Per Modified RECIST v1.1 as Assessed by Investigator
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
• Number of Participants With Shift From Baseline in Clinical Laboratory Parameters
• Change From Baseline in Vital Sign - Systolic and Diastolic Blood Pressure
• Change From Baseline in Vital Sign - Pulse Rate
• Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Index Score at CRT Phase and Maintenance Phase
• Change From Baseline in the European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) VAS Score at CRT Phase and Maintenance Phase
• Change From Baseline in National Cancer Comprehensive Network Head and Neck Symptom Index-22 Item Scores (NCCN FHNSI-22) at CRT Phase and Maintenance Phase
• Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumour Tissue as Assessed by Immunohistochemistry (IHC)
• Mean Percentage (%) of Total Tumour Area Occupied by Cluster of Differentiation 8 (CD8+) Cells
• Percentage of Participants With Positive and Negative Pathology of Neck Dissection
• Maximum Plasma Concentration (Cmax) of Avelumab
• Predose Plasma Concentration (Ctrough) of Avelumab
• Dose Normalized Maximum Plasma Concentration (Cmax [dn]) of Avelumab
• Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Cisplatin
• Maximum Plasma Concentration (Cmax) of Cisplatin
• Clearance (CL) of Cisplatin
• Time to Attain Maximum Observed Plasma Concentration (Tmax) of Cisplatin
• Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status
• Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status

View this trial on ClinicalTrials.gov