MEDI4736 in Recurrent or Metastatic PD-L1 Positive SCCHN
Research type
Research Study
Full title
A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
IRAS ID
165411
Contact name
Hisham Mehanna
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-003295-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
The aim of this phase 2 study is to determine if the medicine MEDI4736 is safe and effective in treating a type of head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN). SCCHN patients whose cancer is recurrent (i.e. returned) or metastatic (i.e. a cancer that has spread) and were previously treated with a platinum-based medicines but their cancer continued to progress during or after treatment will be invited to participate. SCCHN patients within this group have limited treatment options. These options do not provide lasting benefit: currently overall survival rate is 5.5 months and are frequently associated with severe side-effects. Patients within this group will be invited to have their cancers analysed to see if their cancer possess a protein called PD-L1. If the protein is present, the patient can join this study: their participation may last up to 26 months.
Approximately 300 participants aged 18 years or older will be screened for PD-L1 across Europe, Canada and USA, to identify around 115 participants suitable to enrol in the study.
MEDI4736 is a human protein, more specifically an antibody, which has been made in the laboratory. Antibodies are a key part of the immune system that acts to identify, neutralise and remove substances that could cause harm and their ill effects. The study justification is that MEDI4736 can prevent cancer growth by helping boost the ability of the immune system to detect and fight cancer.
This study will also evaluate how much MEDI4736 is in participants’ blood at various times, whether their immune system becomes activated following treatment or their body produces antibodies (proteins produced by the immune system to detect and respond to threats) against MEDI4736, as well as the effect MEDI4736 has on participant’s cancer.REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1164
Date of REC Opinion
28 Jan 2015
REC opinion
Further Information Favourable Opinion