T-WIN – Clinical Trial

Pattern of response/progression to first line treatment with Dabrafenib and Trametenib in patients with Unresectable or Metastatic BRAF Mutation–Positive Cutaneous Melanoma

Prospective observational study involving up to 200 patients from 25 health units:

Patients with histologically confirmed cutaneous melanoma that is either stage IIIC or stage IV, and is BRAF V600E/K or other or other BRAF activating mutation–positive. First treatment with dabrafenib plus trametinib will be independent from participation in this observational study and must not be initiated for the purpose of participating in this study.

– Cohort A): Up to 100 patients  with limited disease burden [LDH ≤ Upper Limit of Normal (UNL), < 3 metastatic sites, no brain metastasis].

– Cohort B): Up to 100 patients with bulky disease (LDH > UNL and/or with brain metastasis).

Patients must meet all of the following inclusion criteria to be eligible for the study:

• Signed and dated informed consent, with age at the time of consent ≥18 years.
• Confirmed BRAF V600E/K or other BRAF activating mutation-positive metastatic melanoma.
• Assigned to treatment with labeled use of combined dabrafenib and trametinib in clinical practice.
• Availability of fresh biopsy or archival tissue at baseline.
• No prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biological therapy, vaccine therapy, or investigational treatment) for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma

Patients must meet none of the following exclusion criteria to be eligible for the study:

• Patients with BRAF wild type metastatic melanoma.
• Patients with no fresh biopsy/archival baseline tissue available.
• Patients who received previous systemic treatment for advanced/metastatic disease.
• Patients assigned to any different treatment other than labeled dabrafenib and trametinib combination as first-line treatment of advanced/metastatic disease.

For more informations refer to Prof. Giuseppe Palmieri

IRGB – Sassari Unit