This trial aims to test safety and effectiveness of the combined treatment with pembrolizumab (Keytruda) and vemurafenib (Zelboraf) in patients with stage 3 or 4 melanoma. The main outcome to be measured will be the response of the tumors to the treatment. This trial is recruiting in Pittsburgh, Pennsylvania (US).
The details
Tumors with a mutation (permanent change) in the BRAF gene are more aggressive. Pembrolizumab inhibits (blocks) BRAF and stimulates the immune system to kill melanoma cells. Vemurafenib is also a BRAF inhibitor that blocks tumor growth. A combination of these two therapies could significantly benefit the patient. However, it is not clear whether they are safe and effective when used in combination.
The current trial will examine combination treatment with pembrolizumab and vemurafenib in patients with advanced melanoma. The main outcome will be measured through tumor response to the treatment and response of the immune system.
Who are they looking for?
This trial will recruit 50 participants with stage 3 and 4 melanoma that cannot be surgically removed. Patients must have a BRAF mutated tumor. Participants must have normal blood values. Participants must not have brain metastasis, cardiovascular disease, autoimmune diseases, pulmonary disease, or bowel disease. Female participants must not be pregnant or breastfeeding, and must agree to use contraception. Participants must not have been treated with BRAF inhibitors before, and must not be using therapies that suppress the immune system.
How will it work
Patients will be treated with pembrolizumab (200 mg) every 3 weeks. Vemurafenib will be given at 480, 720 or 960 mg twice daily. Both therapies will start on the same day. Patients will be followed for up to 2 years or until tumor progression or death. The change in the immune-related overall response rate will be determined following the last treatment and safety will be assessed by the number of patients with severe side effects.
