Home › Hereditary Sensory and Autonomic Neuropathies › 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

Who can join

Ages 1 to 100 · All sexes

Inclusion Criteria:

* Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
* At least 1 measurable lesion as defined by RECIST v1.1 per local review;
* Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
* Ability to provide scans for central imaging review

Exclusion Criteria:

* Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
* Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

About the study

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.

What is being tested

• Non-investigational (other)

Sponsor: Novartis Pharmaceuticals · Participants: 40 · Started: Feb 6, 2024

Contact the study team

• Novartis Pharmaceuticals · Phone: 1-888-669-6682

Official record on ClinicalTrials.gov — NCT05868629

Locations in the U.S.

Conditions

• Hereditary Sensory and Autonomic Neuropathies

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.