Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03551626
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dabrafenib — DRUG
    Supplied as dabrafenib 50 mg and 75 mg capsules for oral administration
  • Trametinib — DRUG
    Supplied as trametinib 0.5mg, and 2.0mg tablets for oral administration

Study Details

The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.

Key Dates

Start date
Aug 29, 2018
Status verified
Apr 2025
Primary completion
Oct 5, 2020
Completion
Sep 16, 2021

Study Design

Enrollment
552 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib and trametinib combination therapy
    Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for up to 12 months.

Primary Outcome Measure

Composite Rate of Pyrexia Related Events [ Time Frame: Baseline up to 12 months ]

Related Studies