Trial Search Results

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

This multi-center, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF-mutation positive melanoma at high risk for recurrence. Patients will be randomized to receive oral doses of vemurafenib 960 mg twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: Vemurafenib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed melanoma of cutaneous origin

   - Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic
   Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been
   completely resected

   - BRAF V600 mutation status of the current primary tumor or involved lymph node
   determined to be positive using the cobas BRAF V600 mutation test

   - Surgically rendered free of disease within 90 days of randomization

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

   - Life expectancy of at least 5 years

   - 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 inherited colon cancer syndromes

   - Known personal history of >3 adenomatous colorectal polyps or a personal history of
   adenomatous colorectal polyp(s) >2 centimeters (cm) in size

   - History of or current clinical, radiographic, or pathologic evidence of in-transit
   metastases, satellite, or microsatellite lesions

   - History of or current clinical, radiographic, or pathologic evidence of recurrent
   lymph node involvement after resection of a primary melanoma with lymph node
   involvement at any time in the past

   - History of local and/or regional and/or distant melanoma recurrence

   - History or current radiographic or pathologic evidence of distant metastases

   - History of clinically significant cardiac or pulmonary dysfunction

   - Major surgical procedure or significant traumatic injury within 4 weeks prior to first
   dose of study treatment

   - Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting