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

Completed · Phase 1

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT02027961

Run by

MedImmune LLC

People needed

68

Starts

2013-12-20

Expected to finish

2018-04-24

Last updated by the study team

2019-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Miami Beach, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Toronto, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Villejuif, France
• Research Site — Naples, Italy

Full record on ClinicalTrials.gov

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