Tumour Biopsy Driven Tx of Metastatic Carcinoma of Head and Neck
Research type
Research Study
Full title
An Exploratory Tumor Biopsy-Driven Study To Understand The Relationship Between Biomarkers And Clinical Response In Immunomodulatory Treatment-Naïve Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of Head And Neck Receiving Regn2810 (Anti-Pd-1)
IRAS ID
222355
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2016-004029-18
Duration of Study in the UK
2 years, 3 months, 12 days
Research summary
This is a phase Ib study for patients suffering from recurrent and/or metastatic head and neck cancer. A metastatic cancer, or metastatic tumour, is one which has spread from the primary site, where it started, into different area of the body.
Cancer cells are different than normal cells in the body and are recognised by the immune system. In some cases the immune system may control or even destroy cancer cells.
A protein in the body called programmed cell death receptor 1 (PD-1) can sometimes block the immune system from destroying cancer cells. The drug investigated in this study, REGN2810, is being investigated as an anti-cancer drug that blocks PD-1 and is expected to help the immune cells destroy cancer cells.
The purpose of this research study is to compare the relationship of response to treatment to changes in the tumour. Other purposes of this study are to assess the relationship of baseline tumour assessments to the response to REGN2810, to assess the safety and tolerability of REGN2810, and to collect any evidence of anti-tumour activity of REGN2810.
This is a single armed (all patients will be assigned one treatment), multicentre study. The study is split into three sections, screening – to check for eligibility, treatment and follow up. If a patient is deemed eligible according to the screening criteria they will receive REGN2810 treatment every 2 weeks for up to 48 weeks.
When a patient is removed from the study they will undergo safety assessments and will be followed up for disease assessment.The study will take place at 2 NHS hospital sites in the UK and 16 patients are expected to be enrolled. A total of approximately 30 patients will be recruited worldwide.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0425
Date of REC Opinion
7 Apr 2017
REC opinion
Further Information Favourable Opinion