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

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT05868629

Run by

Novartis Pharmaceuticals

People needed

40

Starts

2024-02-06

Expected to finish

2028-03-03

Last updated by the study team

2026-04-01

Who can join

Age: 1 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Lundquist Inst BioMed at Harbor — Torrance, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
• Johns Hopkins University — Washington D.C., District of Columbia, United States (enrolling)
• Duke Clinical Research Institute — Durham, North Carolina, United States (enrolling)
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• El Paso Texas Oncology — El Paso, Texas, United States (enrolling)
• Texas Oncology San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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