Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 12, 2013

Primary Completion Date

September 4, 2015

Study Completion Date

September 4, 2015

Conditions
Solid Tumours
Interventions
DRUG

Dabrafenib

Dabrafenib 100 mg or 150 mg BID orally will be administered. Capsules with unit dose strengths of 50 mg or 75 mg

DRUG

Trametinib

Trametinib 1 mg or 2 mg once daily will be administered. Tablets with unit dose strengths of 0.5 mg or 2 mg

DRUG

Ipilimumab

Ipilimumab 3 mg/kg intravenously over 90 minutes Q3W for a total of 4 doses will be administered. Supplied as Vials of 50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL)

Trial Locations (7)

10065

GSK Investigational Site, New York

37232

GSK Investigational Site, Nashville

63110

GSK Investigational Site, St Louis

77030

GSK Investigational Site, Houston

90025

GSK Investigational Site, Los Angeles

94115

GSK Investigational Site, San Francisco

02215

GSK Investigational Site, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01767454 - Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma | Biotech Hunter | Biotech Hunter