EBIN (EORTC 1612-MG)
Research type
Research Study
Full title
Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN)
IRAS ID
246243
Contact name
Heather Shaw
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2017-002887-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 30 days
Research summary
This study is for adults who have BRAF mutated stage III or IV (metastatic) melanoma that cannot be removed surgically. Melanoma is a type of skin cancer. A BRAF mutation is a genetic change inside the melanoma cells which means that they may respond to targeted therapy.
There are two different types of treatment available for people with this type of melanoma; targeted therapies and immunotherapy.
The purpose of this study is to evaluate the effectiveness of combining two targeted therapies with immunotherapy treatment. This is measured by the length of time that participants live with the disease without it getting worse(Progression Free Survival).
The incidence of melanoma has increased in recent years. Currently there is no agreement on which first line treatment is best for this type of cancer. However, targeted thrapies have shown promising results in other clinical trials and may be effective in controlling this type of cancer. There have been no trials that have assessed which is the best treatment sequence which is why the study is being done.
Encorafenib and binimetinib are already used to treat other types of cancer. The information from this study will help doctors learn more about encorafenib and binimetinib as treatments for BRAF mutated stage III or IV (metastatic) melanoma
The study will evaluate the effects of encorafenib and binimetinib and/or nivolumab and ipilimumab using clinical examinations, regular scans and blood tests. The study has a translational research component where tumour and blood samples will also be analysed to understand the effects of the drugs.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
Wales REC 1
REC reference
19/WA/0103
Date of REC Opinion
10 May 2019
REC opinion
Further Information Favourable Opinion