NICO Translational
Research type
Research Study
Full title
Translational analysis of samples collected during the phase II study of neoadjuvant and adjuvant nivolumab in patients with squamous cell carcinoma of the oral cavity treated with surgery and chemoradiotherapy or radiotherapy (NICO)
IRAS ID
296402
Contact name
Joseph Sacco
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Clinicaltrials.gov Identifier
2017-005015-13, NICO main trial EudraCT number
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
NICO TRANSLATIONAL is the analysis of a bioresource collection associated with the NICO Clinical Trial. The NICO Clinical trial is a separately approved and sponsored trial. This protocol describes the translational analysis of the samples collected during the NICO Clinical trial.
The NICO study (IRAS 235386 - now closed to recruitment), investigated the use of the checkpoint inhibitor nivolumab in sequence with standard of care surgery and radiation/chemoradiation in locally advanced oral cavity squamous cell carcinoma. This not only served to discover whether this was a safe approach but also whether patients had an improved one year survival with this strategy. This study provided an invaluable opportunity to collect human biological samples not only at diagnosis but after treatment with neoadjuvant immunotherapy and again at relapse. Following this it is now possible to examine the tumour microenvironment at these points in the patient journey and correlate changes in checkpoint expression and immune infiltrates with outcomes. This unique bioresource will provide a platform to longitudinally investigate the immune cell populations through RNA sequencing, epigenetic analysis, transcriptome and proteomic analysis along with single cell sequencing.
The response rate for patients with recurrent/metastatic head and neck cancer to second line nivolumab has been reported as 13%-18% and as such this planned translational research will aid in identifying much needed predictive biomarkers to highlight a patient group that may respond more readily to immunotherapy. In so doing we may be able to be more selective in choosing adjuvant therapies for patients early on in their treatment course that will avoid exposing them to toxicity for minimal benefit.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0148
Date of REC Opinion
4 May 2021
REC opinion
Favourable Opinion