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

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

Eligibility Criteria

Sex

ALL

Age

1 Year - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Non-investigational — OTHER
  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

Study Details

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 Dates

Start date

Feb 6, 2024

Status verified

Mar 2026

Primary completion

Mar 3, 2028

Completion

Mar 3, 2028

Study Design

Enrollment

40 participants (estimated)

Arms

• Arm: dabrafenib plus trametinib
  patients treated with dabrafenib and trametinib

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Approximately 4 years ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals

Locations (8)

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