Last Update: Apr 01, 2026 Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors ClinicalTrials.gov Identifier: [NCT05868629](https://clinicaltrials.gov/ct2/show/NCT05868629) Novartis Reference Number:CDRB436IIC01 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. Condition Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors Overall Status Recruiting Number of Participants40 Start Date Feb 06, 2024 Completion Date Mar 03, 2028 Gender All Age(s) 1 Year - 100 Years (Child, Adult, Older Adult) ## Interventions 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 ## Eligibility Criteria 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; United States #### Duke Clinical Research Institute Recruiting Durham,North Carolina,27704,United States ###### Aman Opneja ###### Kim Turnage Scoggins Email: #### Oncology Hematology Care Inc Recruiting Cincinnati,Ohio,45242,United States ###### Douglas Hart Email: ###### Jayadev Mettu #### Sarah Cannon Research Institute Recruiting Nashville,Tennessee,37203,United States ###### Brianah Ferby Email: ###### Meredith Ann McKean #### Johns Hopkins University Recruiting Washington D.C.,District of Columbia,20016,United States ###### Kai Hajos Email: ###### Michael Pishvaian #### Lundquist Inst BioMed at Harbor Recruiting Torrance,California,90509-2910,United States ###### Andrew Gianoukakis ###### Steve Yoon Phone: [+1 310 222 4107]() Email: #### El Paso Texas Oncology Recruiting El Paso,Texas,79902,United States ###### Ines Sanchez-Rivera ###### Nicole Dean Email: #### Texas Oncology San Antonio Recruiting San Antonio,Texas,78258,United States ###### Angel Mier-Hicks ###### Norma Norris Email: #### Rocky Mountain Cancer Centers Recruiting Denver,Colorado,80218,United States ###### Muath Dawod ###### Sierra Archuleta Email: ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: