A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Status: | Active, not recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | September 24, 2012 |
End Date: | October 14, 2020 |
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
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.
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.
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
We found this trial at
48
sites
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
100 Medical Plaza Driveway
California City, California 90095
California City, California 90095
Click here to add this to my saved trials
86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
640 Eskenazi Avenue
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1000 East 101st Terrace
Kansas City, Missouri 64131
Kansas City, Missouri 64131
Click here to add this to my saved trials
Click here to add this to my saved trials
11818 Wilshire Boulevard
Los Angeles, California 90025
Los Angeles, California 90025
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
401 East Chestnut Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
333 East 38th Street
New York, New York 10016
New York, New York 10016
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
291 Campus Drive
Stanford, California 94305
Stanford, California 94305
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials