drugset / Trial / NCT03551626

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

NCT03551626

Phase 3 Completed 552 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-08-29
Primary completion
2020-10-05
Completion
2021-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule 150 mg Oral
Subject Trametinib Small molecule 2 mg Oral

Indications