Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

• Status: Completed
• Trial end date: 2018-04-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (WT) BRAF, respectively.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Antibodies, Monoclonal; Dabrafenib; Durvalumab; Trametinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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