skin cancer
Conditions
Interventions
* Cohort 1 (approximately 300 patients) will include patients with completely
resected Stage IIC, IIIA (patients with one or more nodal metastasis > 1 mm in
diameter), or IIIB cutaneous melanoma as
Australia/New
Zealand/South Africa/Latin America
rest of the world)
in Cohort 1 and by region (North America
Australia/New Zealand/South
Africa/Latin America
rest of the world) in Cohort 2.
Within each cohort, patients will receive study treatment according to one of
the following treatment arms:
* Arm A: placebo orally, twice daily (BID) for 52 weeks (th
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients with completely resected, histologically confirmed, Stage IIC or Stage III, cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or involved lymph node is determined to be positive using the cobas® BRAF V600 Mutation Test. Patients with Stage IIIA disease must have at least one lymph node metastasis measuring > 1 mm in diameter * Patients must have been surgically rendered free of disease within 70 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
Exclusion criteria: *History of any systemic or local therapy for the treatment of melanoma *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 *Known personal history of more than three (>3) adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) > 2 cm in size.This also applies to the screening colonoscopyfor select patients. *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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Outcome Measures * Disease-free survival (DFS) will be defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence ; occurrence of new primary melanoma; or death from any cause. The DFS component of melanoma recurrence will be assessed by the investigator. The DFS component of an occurrence of a new primary melanoma will be based upon the diagnosis made by a Roche-designated central pathology laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| * OS will be defined as the time from randomization to the date of death from any cause. * DMFS will be defined as the time from randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause. | — |
Countries
Netherlands
Outcome results
None listed