CompletedPhase 3

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

Argentina, Australia552 participantsStarted 2018-08-29

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma were eligible.
✓. Subjects who had previously had Stage III melanoma at any time were not eligible.
✓. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).

What they're measuring

Composite Rate of Pyrexia Related Events

Timeframe: Baseline up to 12 months

Trial details

NCT IDNCT03551626

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-05

Results submitted2022-09-15

View on ClinicalTrials.gov More Malignant Melanoma trials