Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-investigational.
- Who it may be relevant to
- Registry conditions: Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors. Basic parameters: 1 year — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Non-investigational
Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program
Primary outcome measures
- Overall Response Rate (ORR) [Time frame: Approximately 4 years]
Secondary outcome measures (2)
- Duration of response (DOR) [Time frame: Approximately 4 years]
- Clinical benefit rate (CBR) [Time frame: Approximately 4 years]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 8 centers
- Lundquist Inst BioMed at Harbor — Torrance
- Rocky Mountain Cancer Centers — Denver
- Johns Hopkins University — Washington D.C.
- Duke Clinical Research Institute — Durham
- Oncology Hematology Care Inc — Cincinnati
- Sarah Cannon Research Institute — Nashville
- El Paso Texas Oncology — El Paso
- Texas Oncology San Antonio — San Antonio
Identifiers
NCT: NCT05868629 · CDRB436IIC01