Actively Recruiting

Age: 1Year - 100Years
All Genders
NCT05868629

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

Led by Novartis Pharmaceuticals · Updated on 2026-04-01

40

Participants Needed

8

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a solid tumor confirmed to have the BRAF V600E mutation by a local lab test
  • Have at least one measurable tumor lesion as defined by RECIST v1.1
  • Have not been treated with dabrafenib or trametinib before, or have stopped these treatments for other cancers more than 1 year ago
  • Are able to provide scans for central imaging review
Not Eligible

You will not qualify if you...

  • Have melanoma, non-small cell lung cancer, anaplastic thyroid cancer, biliary tract cancer, glioma, or colorectal cancer
  • Have any contraindications to receive dabrafenib or trametinib based on local guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Lundquist Inst BioMed at Harbor

Torrance, California, United States, 90509-2910

Actively Recruiting

2

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

Actively Recruiting

3

Johns Hopkins University

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

4

Duke Clinical Research Institute

Durham, North Carolina, United States, 27704

Actively Recruiting

5

Oncology Hematology Care Inc

Cincinnati, Ohio, United States, 45242

Actively Recruiting

6

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

7

El Paso Texas Oncology

El Paso, Texas, United States, 79902

Actively Recruiting

8

Texas Oncology San Antonio

San Antonio, Texas, United States, 78258

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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