Treatment Study For Patients With Advanced BRAFV600 Mutant Melanoma
To provide combination treatment involving dabrafenib, trametinib, ipilimumab, and nivolumab for patients with advanced BRAFV600 mutant melanoma and to collect additional data on treatment safety.
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Have an ECOG performance status of 0 or 1.
- Have unresectable stage III or stage IV disease.
- Have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization.
- Have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.
- Have BRAFV600 E or K mutant melanoma (whether cutaneous, acral or mucosal primary).
- Have BRAFV600E or BRAFV600K mutations.
- Have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a cytotoxic T-lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PD1) pathway blocking antibody or a BRAF/MEK inhibitor.
- Have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting ≥ 4 weeks prior to entering the study.
You will be excluded from the study if any of the following criteria apply to you:
- Have uveal melanoma.
- Have had any prior systemic treatment for advanced (measurable metastatic) disease.
- Have currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks of randomization could be eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible.
- Have no history of or evidence of cardiovascular risks/disease, history of retinal vein occlusion (RVO), evidence of interstitial lung disease or pneumonitis.
- Have malabsorption or swallowing difficulty.
This is a partial list of inclusion and exclusion criteria.