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Clinical Trial VICCMEL1256

Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of Vemurafenib (RO5185426) Adjuvant Therapy In Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma At High Risk For Recurrence

Principal Investigator(s)

Jeffrey Sosman

Details

  • Protocol No. VICCMEL1256
  • Open Date: 12/06/2012
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To evaluate the efficacy of vemurafenib adjuvant treatment administered over a 52-week period in patients with completely resected BRAFV600 mutation positive, cutaneous melanoma, as measured by DFS
  • Disease Sites: Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: PLX4032; RO5185426 (Vemurafenib); Vemurafenib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01667419
  • Secondary Protocol No: G027826

Description

Participants are being asked to take part in this research study because they have adjuvant (surgically removed) cutaneous melanoma (a type of skin cancer). The purpose of this study is to find out whether the study drug, vemurafenib, can help prevent or delay the return of melanoma that is at a high risk of returning (Stage IIC, IIIA, IIIB or IIIC) after it has been removed surgically. The study will also assess whether the drug causes side effects in patients.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• All patients should have histologically confirmed melanoma of cutaneous origin
• Patients must have been surgically rendered free of disease within 90 days of randomization
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Life expectancy of at least 5 years
• Patients must have fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
• Adequate hematologic, hepatic and renal function
Exclusion Criteria:
• History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
• History of limb perfusion therapy
• History of radiotherapy for the treatment of melanoma
• Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
• Family history of colon cancer syndromes
• History of clinically significant cardiac or pulmonary dysfunction
• Major surgical procedure within 4 weeks prior to first dose of study treatment
• Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus