Avelumab with SOC Chemoradiotherapy in Head and Neck Cancer
Research type
Research Study
Full title
A Randomized Double-Blind Phase 3 Study of Avelumab in Combination with Standard of Care Chemoradiotherapy (Cisplatin plus Definitive Radiation Therapy) Versus Standard of Care Chemoradiotherapy in the Front-Line Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
IRAS ID
219158
Contact name
Gemma Sheppard
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2016-001456-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 8 days
Research summary
Head and neck cancers, including cancers of the oral cavity, nasopharynx, pharynx, and larynx, account for approximately 5% of cancers worldwide. Currently available treatment options for both locoregional and distant recurrences are limited. Outcomes for both groups of recurrences are abysmal, and the limited numbers of patients who are eligible for potentially curative treatment for locoregional disease recurrence are exposed to a high degree of morbidity.
The main purpose of this study is to compare the effects of the study drug, avelumab (MSB0010718C) in combination with standard of care (SOC) chemoradiotherapy to placebo in combination with SOC chemoradiotherapy. The chemotherapy drugs that will be used in this study are cisplatin plus radiation therapy. The study drug is avelumab (MSB0010718C).
This study will focus on patients with locally advanced cancer of the head and neck, who are ≥18 years and meet the inclusion criteria.
This study consists of 3 phases: a Lead-in phase, a Chemoradiotherapy phase, and a Maintenance phase.
In the Lead-in phase, participants will receive either avelumab or placebo single dose via IV.
In the chemotherapy phase, patients will receive chemoradiotherapy in combination with avelumab or placebo. The screening, Lead-in phase, Chemoradiotherapy phase, and Maintenance phase, together will last for approximately 15 months. The Maintenance phase of the study will last 12 months.Patients will be randomly assigned to treatment by a computer system. Participants will have a 1 in 2 (50%) chance of receiving avelumab or placebo.
Patients would need to provide an archived tumour bio-specimen, and need to provide a fresh tumour sample during the study.
There will be about 640 people taking part in this study. The study is being done at approximately 200 different research sites in 20 countries.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0228
Date of REC Opinion
5 May 2017
REC opinion
Favourable Opinion