CA209-714
Research type
Research Study
Full title
A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in Combination with Ipilimumab Placebo In Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
IRAS ID
218036
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-001645-64
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 125872
Duration of Study in the UK
6 years, 6 months, 3 days
Research summary
Research Summary
This is a multicentre, double-blind, phase II study of two investigational drugs; Nivolumab and Ipilimumab, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Approximately 315 patients will take part globally, 15 of these will be in the UK. The study is sponsored by Bristol-Myers Squibb. The purpose of the study is to compare the response of the cancer between patients receiving a combination of Nivolumab and Ipilimumab to patients receiving Nivolumab and a placebo.
Metastatic or recurrent Head and Neck Cancer remains an area of high unmet medical need, with most patients surviving for less than 12 months with the current standard treatments. In a sub-set of patients that progress after platinum based therapy (referred to as platinum refractory), about half of these patients survive for less than 6 months and there are no well-established treatment options.
Following a screening period, eligible patients be randomized to receive either Nivolumab and Ipilimumab or Nivolumab and a placebo. All treatments will be given intravenously with Nivolumab given every 2 weeks and ipilimumab or placebo every 6 weeks.Patients will undergo the following study procedures: Tumour biopsy (if not already available), CT/MRI scans, physical exams, vital signs such as blood pressure, height, weight, body temperature and blood tests for routine safety testing and study specific testing. Patients will also be required to complete questionnaires at regular intervals throughout the study to assess their quality of life.
Patients can remain in the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. If any patient continues to benefit from the study treatment at the end of the study, the study sponsor will make provisions for the continuing treatment of that patient.Summary of Results
No plain language summary (PLS) will be available.
Technical results will be posted on clinicaltrials.gov.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0028
Date of REC Opinion
7 Feb 2017
REC opinion
Further Information Favourable Opinion