Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02625337
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
  • Dabrafenib — DRUG
  • Trametinib — DRUG
  • Biopsy — PROCEDURE
    Biopsies will be taken during screening, before randomization, at week 8 (only arm 2-4) after 12 weeks, at week 18 and if PD.
  • Blood taking — PROCEDURE
    Blood will be taken for PBMCs during screening (twice), before randomization, at weeks 12 at week 18 and if PD.

Study Details

This is a Phase 2 trial consisting of 24 patients receiving the combination of dabrafenib + trametinib + pembrolizumab in 3 different dosing schemes and 8 patients receiving pembrolizumab standard monotherapy. All patients start with pembrolizumab standard therapy for 6 weeks and will then be randomized to continue pembrolizumab monotherapy or to receive additional intermitted/short-term dabrafenib + trametinib. Stratification will be baseline LDH level and baseline PD-L1 expression.

Key Dates

Start date
Jan 31, 2016
Status verified
Sep 2017
Primary completion
Jun 30, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pembrolizumab mono
    Pembrolizumab monotherapy
  • Experimental: Pembrolizumab with dabrafenib+trametinib short
    Pembrolizumab combined with a short scheme of dabrafenib+trametinib
  • Experimental: Pembrolizumab with dabrafenib+trametinib intermediate
    Pembrolizumab combined with an intermediate scheme of dabrafenib+trametinib
  • Experimental: Pembrolizumab with dabrafenib+trametinib long
    Pembrolizumab combined with a long scheme of dabrafenib+trametinib

Primary Outcome Measure

Safety of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapy as measured by SUSARs. [ Time Frame: 18 weeks from baseline ]

Central Contacts

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