Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01682083
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dabrafenib — DRUG
    Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)
  • Trametinib — DRUG
    Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
  • Placebos — DRUG
    The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment

Study Details

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk (Stage IIIa \[lymph node metastasis \>1 mm\], IIIb or IIIc) cutaneous melanoma were screened for eligibility. Approximately 852 patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc). Patients received either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or 2 matching placebos (one each for dabrafenib and trametinib) for 12 months or until disease recurrence, death, unacceptable toxicity, or withdrawal of consent. Patients were followed for disease recurrence and survival during and after the treatment period. The study did not permit crossover. Doses of study treatment could be modified and/or interrupted for management of toxicities associated with study treatment.

Key Dates

Start date
Jan 8, 2013
Status verified
Apr 2026
Primary completion
Jun 30, 2017
Completion
Jul 31, 2023

Study Design

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

Arms

  • Experimental: Dabrafenib and trametinib
    Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
  • Placebo Comparator: Dabrafenib and trametinib placebos
    Subjects received matching placebos orally for 12 months

Primary Outcome Measure

Percentage of Participants With Relapse-free Survival (RFS) Events [ Time Frame: Approximately 4 years ]

Locations (20)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBirminghamAlabama35243-
Novartis Investigative SiteTucsonArizona85724-
Novartis Investigative SiteSan FranciscoCalifornia94115-
Novartis Investigative SiteSan FranciscoCalifornia94143-
Novartis Investigative SiteAuroraColorado80045-
Novartis Investigative SiteLake WorthFlorida33461-
Novartis Investigative SiteOrlandoFlorida32806-
Novartis Investigative SiteTampaFlorida33612-
Novartis Investigative SiteAtlantaGeorgia30322-
Novartis Investigative SiteAtlantaGeorgia30341-
Novartis Investigative SiteLutherville-TimoniumMaryland21093-
Novartis Investigative SiteBostonMassachusetts02114-
Novartis Investigative SiteBostonMassachusetts02115-
Novartis Investigative SiteAnn ArborMichigan48019-
Novartis Investigative SiteWinston-SalemNorth Carolina27157-
Novartis Investigative SiteColumbusOhio43210-
Novartis Investigative SitePortlandOregon97123-
Novartis Investigative SitePittsburghPennsylvania15232-
Novartis Investigative SiteNashvilleTennessee37203-
Novartis Investigative SiteDallasTexas75390-

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Novartis Investigative Site· Birmingham, ALNovartis Investigative Site· Tucson, AZNovartis Investigative Site· San Francisco, CANovartis Investigative Site· Aurora, CONovartis Investigative Site· Lake Worth, FLNovartis Investigative Site· Orlando, FL

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