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

Novartis

Status

Enrolling

Conditions

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Treatments

Other: Non-investigational

Study type

Observational

Funder types

Industry

Identifiers

NCT05868629

CDRB436IIC01

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

1 to 100 years old

Volunteers

No Healthy Volunteers

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;