NCT05868629

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year – 100 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.

Conditions

• Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Interventions

Type	Name	Description
OTHER	Non-investigational	Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program

Timeline

• Start date: 2024-02-06
• Primary completion: 2028-03-03
• Completion: 2028-03-03
• First posted: 2023-05-22
• Last updated: 2026-04-01

Locations

8 sites across 1 country: United States