CA2099TM Phase 3 Nivolumab SCCHN
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab plus Cisplatin, in Combination with Radiotherapy in Participants with Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
IRAS ID
235821
Contact name
Rafael Moleron
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-002676-87
Duration of Study in the UK
6 years, 11 months, 29 days
Research summary
Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumour cells. Nivolumab is currently being studied for treatment of head and neck cancer patients who have not received prior chemotherapy before for this disease area. The combination of radiotherapy (RT) and cisplatin is considered to be a standard therapy for the initial treatment of head and neck cancer for those who can tolerate cisplatin. The purpose of this study is to compare the combination treatment of nivolumab and cisplatin (non-study drug) and RT to the combination treatment of cisplatin and RT. For patients that cannot tolerate cisplatin another drug, cetuximab (another antibody) is an alternative treatment, a second cohort compares the combination treatment of nivolumab (study drug) and RT to the combination treatment of cetuximab (non-study drug) and RT. This study will compare these combinations for their effectiveness, safety, and how well the patient copes. The study will take place in specialist Oncology centres under the care of an Oncology team. The duration of the study will be potentially up to 6 years, including initial screening for eligibility, treatment and follow-up (depending on survival).
Tests undertaken will include but are not limited to; physical exam, vital signs, height, weight, pregnancy test, MRI, electrocardiogram, and questionnaires, blood and tissue tests.REC name
West of Scotland REC 1
REC reference
18/WS/0023
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion