CA209-651: 1st Line Nivo & Ipi vs EXTREME in HNSCC
Research type
Research Study
Full title
An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
IRAS ID
208568
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-000725-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
125872, IND Number
Duration of Study in the UK
3 years, 2 months, 0 days
Research summary
Summary of Research
This is a multicentre, phase III study involving two investigational drugs called Nivolumab and Ipilimumab in patients with untreated metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN).
Approximately 490 patients will take part globally with 30 of this number being recruited in the UK. The study is sponsored by Bristol-Myers Squibb.
The purpose of the study is to compare the survival of patients receiving Nivolumab and Ipilimumab to Investigator’s Choice, in subjects who have tumour progression within 6 months of last dose of platinum therapy in the primary, recurrent, or metastatic setting.
Despite numerous treatment options, metastatic or recurrent Head and Neck Cancer remains an area of high unmet medical need. Patients who progress after treatment (refractory or platinum-resistant disease) have the worst prognosis with median Overall Survival of 3 - 4 months and 1 year survival rate of < 5%. In conclusion, there is no effective standard of care that provides survival benefits beyond 4 - 6 months in second line platinum refractory recurrent or metastatic Squamous Cell Head and Neck Carcinoma. Following a screening period, eligible patients will receive study drug intravenously every week or every 2 weeks (for Nivolumab), and every 6 weeks (for Ipilumumab). 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 a questionnaire 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. At the conclusion of the study, patients who continue to gain clinical benefit from Nivolumab and Ipilimumab may be eligible to continue treatment.Summary of Results
Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS)
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0484
Date of REC Opinion
5 Oct 2016
REC opinion
Favourable Opinion