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

NCT05868629

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Interventions: Non-investigational

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 1 Year to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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;

Locations (8)

Torrance, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
El Paso, Texas, United States
San Antonio, Texas, United States