PORTSIDE
Research type
Research Study
Full title
A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB ANDBINIMETINIB PLUS PEMBROLIZUMAB VERSUS NIVOLUMAB ANDIPILIMUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVEMELANOMA WHO PROGRESSED DURING OR AFTERPRIOR TREATMENT WITH ANTI−PD-1 THERAPY
IRAS ID
1006562
Contact name
Adam Schayowitz
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-003640-24
Research summary
This study is in patients that have unresectable (inoperable) or metastatic melanoma (a serious form of skin cancer that has spread to other parts of your body) that has a specific mutation of the BRAF gene (the V600E or V600K mutation). Patients will have previously been treated with either nivolumab or pembrolizumab, but the tumour was resistant to this treatment and continued to grow. This study is asking which second treatment is better for these patients whose tumours did not respond to their first anti-cancer treatment.
150 patients will be randomly assigned to receive either encorafenib and binimetinib in combination with pembrolizumab, or an approved combination treatment (nivolumab and ipilimumab). The combination of encorafenib and binimetinib is approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Pembrolizumab is approved for patients with unresectable or metastatic melanoma regardless of BRAF mutation status. However, the triplet therapy of encorafenib, binimetinib, and pembrolizumab given together has not been approved.
Encorafenib and binimetinib are taken orally (by mouth) every day; pembrolizumab, nivolumab and ipilumab are given intravenously (though a needle in a vein or port)
Patients will initially attend the study clinic for a screening visit to ensure they are suitable for the study, and then they will visit the clinic every 3 or 4 weeks (depending on the treatment group). They will continue to receive the study treatments if they are benefitting for a maximum of 2 years for pembrolizumab and nivolumab. Besides receiving study treatments at each visit, patients will also have regular blood tests, physical examinations, cardiac assessments, eye tests, skin examinations, CT/MRI scans, and they will complete quality of life questionnaires.
The study is funded by Pfizer and will take place in 13 countries, mostly in Europe.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0048
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion