A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Part of paid clinical trials in Encinitas, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02967692
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Spartalizumab — BIOLOGICAL
    Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks
  • Placebo — OTHER
    Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks
  • Dabrafenib — DRUG
    Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.
  • Trametinib — DRUG
    Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions

Study Details

The purpose of this study was to evaluate safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in patients with BRAF V600 mutant, unresectable and metastatic melanoma.

Key Dates

Start date
Feb 17, 2017
Status verified
Sep 2025
Primary completion
Aug 11, 2020
Completion
Aug 21, 2024

Study Design

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

Arms

  • Experimental: Part 1: Safety run-in Cohort
    In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
  • Experimental: Part 2: Biomarker cohort
    In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
  • Experimental: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib
    In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
  • Placebo Comparator: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib
    In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)

Primary Outcome Measure

Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 8 weeks (Part 1) ]

Locations (12)

FacilityCityStateZIPSite coordinators
California Cancer Associates for Research and ExcellenceEncinitasCalifornia92024-
UC Irvine Medical CenterOrangeCalifornia92613-4091-
California Pacific Medical CenterSan FranciscoCalifornia94115-
Stanford Cancer CenterStanfordCalifornia94305-
University of Kansas Cancer CenterWestwoodKansas66205-
Johns Hopkins ULuthervilleMaryland21093-
Nebraska Cancer SpecialistsOmahaNebraska68130-
NYU Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
University of Pittsburgh Med CenterPittsburghPennsylvania15213-
University of Tennessee Medical CtrKnoxvilleTennessee37920-
Univ of TX MD Anderson Cancer CntrHoustonTexas77030-
Utah Cancer SpecialistsSalt Lake CityUtah84106-

Find similar trials in Encinitas, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
California Cancer Associates for Research and Excellence· Encinitas, CAUC Irvine Medical Center· Orange, CACalifornia Pacific Medical Center· San Francisco, CAStanford Cancer Center· Stanford, CAUniversity of Kansas Cancer Center· Westwood, KSJohns Hopkins U· Lutherville, MD

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