Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation

Conditions

• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo surgery
• Trametinib — DRUG
  Given PO

Study Details

This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.

Key Dates

Start date

Oct 22, 2014

Status verified

Feb 2026

Primary completion

Apr 1, 2027

Completion

Apr 1, 2027

Study Design

Enrollment

58 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (dabrafenib, trametinib, surgery)
  Patients receive dabrafenib PO BID and trametinib PO QD for 8 weeks. After completion of 8 weeks of dabrafenib and trametinib, patients undergo surgery. Approximately 1 week after surgery, patients receive dabrafenib PO BID and trametinib PO QD for 44 additional weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: Up to 1 year ]

Locations (1)

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