Recruiting

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT05868629

Conditions

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Interventions

Non-investigational

Study Details

Brief 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

Study ID

NCT05868629

Start date

Feb 6, 2024

Status verified date

Mar, 2026

Completion date

Mar 3, 2028

Anticipated

Primary completion date

Mar 3, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

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;

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

dabrafenib plus trametinib

patients treated with dabrafenib and trametinib

Interventions

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

Primary outcome measure

Overall Response Rate (ORR) [ Time Frame: Approximately 4 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Locations

Lundquist Inst BioMed at Harbor

Recruiting

Torrance, California, United States, 90509-2910

Contacts

Steve Yoon

+1 310 222 4107 syoon@lundquist.org

Principal Investigator:

Andrew Gianoukakis

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Contacts

Sierra Archuleta

sierra.archuleta@usoncology.com

Principal Investigator:

Muath Dawod

Johns Hopkins University

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Kai Hajos

khajos1@jhmi.edu

Principal Investigator:

Michael Pishvaian

Duke Clinical Research Institute

Recruiting

Durham, North Carolina, United States, 27704

Contacts

Kim Turnage Scoggins

kim.scoggins@duke.edu

Principal Investigator:

Aman Opneja

Oncology Hematology Care Inc

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Douglas Hart

Douglas.Hart@usoncology.com

Principal Investigator:

Jayadev Mettu

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Brianah Ferby

brianah.ferby@scri.com

Principal Investigator:

Meredith Ann McKean

El Paso Texas Oncology

Recruiting

El Paso, Texas, United States, 79902

Contacts

Nicole Dean

nicole.dean@usoncology.com

Principal Investigator:

Ines Sanchez-Rivera

Texas Oncology San Antonio

Recruiting

San Antonio, Texas, United States, 78258

Contacts

Norma Norris

norma.norris@usoncology.com

Principal Investigator:

Angel Mier-Hicks

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

BRAF
v-raf murine sarcoma viral oncogene homolog B1
dabrafenib
trametinib
tumor agnostic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-04-01.