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Keep this study
Lead
MedImmune LLC
This is a multicenter, open-label study with a dose escalation phase followed by an expansion phase of durvalumab administered in combination with dabrafenib and trametinib or with trametinib alone in participants with BRAF V600 mutation-positive and WT unresectable or metastatic melanoma, respectively.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults \>= 18 years old
Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable) or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive (cohort A) or mutation-negative (cohorts B and C)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease by radiographic or physical examination
Adequate organ and marrow function
Willingness to provide consent for biopsies positive or BRAF WT measurable disease and adequate organ and marrow function
You may not be if
Prior treatment with a BRAF inhibitor or MEK inhibitor
Any prior Grade \>= 3 immune-related adverse event while receiving immunotherapy
Active or prior documented autoimmune disease within the past 2 years
History of or current risk for retinal vein occlusion (RVO) or central serous retinopathy (CSR)
History of or current cardiovascular risk including myocardial infarction, \>= Class II congestive heart failure, uncontrolled arrhythmias, or refractory hypertension
Active, untreated central nervous system (CNS) metastases
Women who are pregnant or lactating
Clareo Health | Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone
