OBERON - Cetuximab immunotherapy combination in head and neck cancer
Research type
Research Study
Full title
Phase I/Ib trial of durvalumab (MEDI4736), tremelimumab + cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck - OBERON
IRAS ID
234817
Contact name
Robert Metcalf
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Eudract number
2017-003589-28
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Summary of Research
Squamous cell carcinoma of the head and neck (SCCHN) includes tumours of the mouth, throat and voice box. Smoking, alcohol intake and infection with human papilloma virus (HPV) all increase the risk of developing SCCHN. With current treatment options, the average survival time for patients diagnosed with SCCHN which has returned or spread is approximately 10 months. Less than 10% of these patients survive for 3 years. It is therefore important to develop new treatment options, to be used where standard treatment has not worked.
Researchers have found that sometimes the body’s own immune system may slow down or control cancer growth. Sometimes, this natural immune system response stops and the cancer is not killed in this way. Research has shown that in some patients, cancer cells and immune cells express signals which stop the immune system from killing the cancer. New drugs are being developed to block these signals and increase the immune response against cancer cells. In this study a combination of two such experimental drugs, durvalumab and tremelimumab, with cetuximab (a drug already licensed and used in the treatment of SCCHN) will be tested for the first time in patients whose cancer has recurred or spread.
This research will look at whether this combination of drugs is safe and whether side effects are manageable. It will also assess the proportion of patients who have responded well to treatment, by measuring tumour size at intervals throughout the study.
There are two parts to the study. In the first part the dose of cetuximab will be increased in stages to determine the recommended dose (dose escalation). In the second part the recommended dose will be tested (dose expansion).
Astra Zeneca is funding this study. All study treatment will take place in NHS hospitals specialising in experimental SCCHN treatment.
Summary of Results
The study funding has been stopped before the protocol-defined study start date was achieved. Therefore, the regulatory Study Green Light was not completed. There were no sites open and no participants were recruited, and therefore no data were collected.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0225
Date of REC Opinion
3 Oct 2018
REC opinion
Further Information Favourable Opinion