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A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects With Metastatic or Unresectable Melanoma in Combination With Dabrafenib and Trametinib or With Trametinib Alone
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.
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 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 20, 2013
Primary Completion Date
April 24, 2018
Completion Date
April 24, 2018
Last Updated
May 17, 2019
68
ACTUAL participants
Durvalumab
BIOLOGICAL
Dabrafenib
DRUG
Trametinib
DRUG
Lead Sponsor
MedImmune LLC
NCT06066138
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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