Last Update: Apr 10, 2024
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
Novartis Reference Number:CDRB436IIC01
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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 (6 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.

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
Recruiting
40
Feb 06, 2024
Feb 29, 2028
All
6 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;

Study Location

Duke Clinical Research Institute .

Recruiting

Durham,Emily Bolch email: [email protected] -- John Strickler,27704 - North Carolina,United States

Worldwide Contacts

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Novartis Pharmaceuticals

1-888-669-6682