MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2025-04-29

Study results available
· View outcomes & findings →

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.

Conditions

  • Malignant Melanoma

Interventions

DRUG

Dabrafenib

Supplied as dabrafenib 50 mg and 75 mg capsules for oral administration

DRUG

Trametinib

Supplied as trametinib 0.5mg, and 2.0mg tablets for oral administration

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Argentina
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Finland
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Slovenia
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551626 on ClinicalTrials.gov