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)
NCT02952586 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 697
Last updated 2021-09-22
Summary
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor 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.
Conditions
- Squamous Cell Carcinoma of the Head and Neck
Interventions
- DRUG
-
Avelumab
Avelumab + SOC Chemoradiation
- OTHER
-
Chemoradiation
Cisplatin + Radiation Therapy
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-28
- Primary Completion
- 2019-12-23
- Completion
- 2020-08-25
Countries
- United States
- Australia
- Austria
- Belgium
- Canada
- China
- France
- Germany
- Greece
- Hungary
- Ireland
- Israel
- Italy
- Japan
- Poland
- Portugal
- Russia
- South Korea
- Spain
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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