NCT02027961

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Intravenous dose of 3 or 10 mg/kg durvalumab.
DRUG	Dabrafenib	Oral dose of 150 mg dabrafenib capsule.
DRUG	Trametinib	Oral dose of 2 mg trametinib tablet.

Timeline

• Start date: 2013-12-20
• Primary completion: 2018-04-24
• Completion: 2018-04-24
• First posted: 2014-01-06
• Last updated: 2019-05-17

Locations

11 sites across 4 countries: United States, Canada, France, Italy

Regulatory

• FDA-regulated drug study