A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Vemurafenib; Placebo
Intervention description: 4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.; Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Intervention MeSH terms: Vemurafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
      efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF
      mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two
      separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA
      (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in
      diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer
      (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC
      cutaneous melanoma, as defined by this classification scheme. Within each cohort,
      participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a
      52-week period.
    

Eligibility criteria:

        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