BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma

Sponsor
Haukeland University Hospital
Study ID
NCT02872259
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of the study is to assess the safety and efficacy of BGB324 given together with standard treatment, pembrolizumab or dabrafenib and trametinib, compared to standard treatment alone,

Key Dates

Start date
Feb 13, 2017
Status verified
Jan 2025
Primary completion
May 23, 2024
Completion
May 23, 2024

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BGB324 + pembrolizumab
    BGB324 capsules, 200 mg once daily + pembrolizumab 2 mg/kg IV every 3. week Treatment until disease progression, or unacceptable toxicity
  • Experimental: BGB324 + dabrafenib and trametinib
    BGB324 capsules: Dose finding part of the study will determine if 100 mg once daily should be used for main part of the study or if 200 mg once daily once daily should be used. Dabrafenib capsules: 150 mg twice daily Trametinib tablets: 2 mg once daily Treatment until disease progression, or unacceptable toxicity
  • Active Comparator: pembrolizumab
    Pembrolizumab 2 mg/kg IV every 3. week Treatment until disease progression, or unacceptable toxicity
  • Active Comparator: dabrafenib and trametinib
    Dabrafenib capsules:150 mg twice daily Trametinib tablets: 2 mg once daily Treatment until disease progression, or unacceptable toxicity

Primary Outcome Measure

Objective Response Rate (ORR) assessed according to RECIST Version 1.1 [ Time Frame: through study completion, an average of 1 year ]

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