RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-02-06
Study Completion:2028-03-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05868629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
  2. * At least 1 measurable lesion as defined by RECIST v1.1 per local review;
  3. * 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;
  4. * Ability to provide scans for central imaging review
  1. * Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
  2. * Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
United States
Johns Hopkins University
Washington D.C., District of Columbia, 20016
United States
Duke Clinical Research Institute
Durham, North Carolina, 27704
United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
El Paso Texas Oncology
El Paso, Texas, 79902
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-06
Study Completion Date2028-03-03

Study Record Updates

Study Start Date2024-02-06
Study Completion Date2028-03-03

Terms related to this study

Keywords Provided by Researchers

  • BRAF
  • v-raf murine sarcoma viral oncogene homolog B1
  • dabrafenib
  • trametinib
  • tumor agnostic

Additional Relevant MeSH Terms

  • Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors