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
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Brief Summary
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This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 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
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Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

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

Intervention / Treatment
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* Other: Non-investigational


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dabrafenib plus trametinib<br>patients treated with dabrafenib and trametinib | Other: Non-investigational<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria. | Approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response (DOR) | Defined as time from the onset of tumor response until the date of the first documented progressive disease (PD) or death due to any cause. | Approximately 4 years | 
| Clinical benefit rate (CBR) | Defined as the proportion of study participants with a best overall response of CR, PR or stable disease (SD), lasting as per independent central review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST v1.1. or other relevant response criteria. | Approximately 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRAF, v-raf murine sarcoma viral oncogene homolog B1, dabrafenib, trametinib, tumor agnostic