Study on Dabrafenib and Trametinib Before and After Surgery for Stage IIIB-C Melanoma with BRAF V600 Mutation

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02231775

Provider View

This clinical trial is testing the effectiveness of using the drugs dabrafenib and trametinib before and after surgery to treat patients with stage IIIB-C melanoma that has a specific BRAF V600 mutation. The study aims to see if these drugs can shrink tumors before surgery and eliminate remaining cancer cells after surgery.

Patient Parameters

Program Overview

This study is exploring how well the drugs dabrafenib and trametinib work when given before and after surgery in patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. These drugs may help stop tumor growth by blocking certain enzymes needed for cell growth. Taking these drugs before surgery might shrink the tumor, making it easier to remove, while taking them after surgery could help kill any leftover cancer cells.

Description

The main goal of this study is to compare how long patients remain free of cancer after treatment, depending on whether their cancer completely disappears after taking dabrafenib and trametinib before surgery. Researchers will also look at overall survival rates and try to identify markers that predict how well patients respond to the treatment by collecting blood samples and biopsies. The safety of the drug combination will also be evaluated.

Patients will take dabrafenib twice a day and trametinib once a day for 8 weeks before undergoing surgery. About a week after surgery, they will continue taking the drugs for an additional 44 weeks, as long as the cancer does not progress or cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits every 3 months for a year.

Eligibility Criteria

Inclusion Criteria

  • Able to give written consent and follow study requirements.
  • Diagnosed with stage IIIB/C melanoma that can be surgically removed, as confirmed by a medical team.
  • Medically fit for surgery.
  • Have melanoma with a BRAF V600E or V600K mutation, confirmed by a certified lab.
  • Have measurable cancer according to specific criteria.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Meet specific blood count and organ function requirements.
  • Men must agree to use effective contraception during and after the study.
  • Women must either be unable to have children or agree to use effective contraception during and after the study.

Exclusion Criteria

  • Currently receiving other cancer treatments or investigational drugs.
  • Have used BRAF or MEK inhibitors before.
  • Have had another cancer, except for certain types that have been treated and are in remission.
  • Recent major surgery within the last 3 weeks.
  • Have certain eye conditions or risk factors for them.
  • Have active gastrointestinal disease affecting drug absorption.
  • Have untreated brain or bone metastases.
  • Have certain heart conditions or uncontrolled medical issues.
  • Pregnant or breastfeeding women.
  • Unable or unwilling to follow study procedures.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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