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

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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.


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
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Aurora, Colorado 80045
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2035 Paraguay
Buenos Aires, C1121
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100 Medical Plaza Driveway
California City, California 90095
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
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Durham, North Carolina 27710
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Fort Myers, Florida 33905
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Germantown, Tennessee 38138
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Grand Junction, Colorado 81501
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Hayward, California 94545
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Hollywood, Florida
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Houston, Texas 77030
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640 Eskenazi Avenue
Indianapolis, Indiana 46202
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Irvine, California 92604
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Kansas City, Missouri 64111
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1000 East 101st Terrace
Kansas City, Missouri 64131
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La Jolla, California 92093
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11818 Wilshire Boulevard
Los Angeles, California 90025
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Morgantown, West Virginia 26506
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300 20th Avenue North
Nashville, Tennessee 37203
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333 East 38th Street
New York, New York 10016
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3600 Broadway
Oakland, California 94611
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Oakland, California 94611
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Park Ridge, Illinois 60068
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625 South Fair Oaks Avenue
Pasadena, California 91105
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Philadelphia, Pennsylvania 19104
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100 Madison Avenue
Randolph, New Jersey 07869
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Roseville, California 95678
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Sacramento, California 95825
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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San Francisco, California 94115
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275 Hospital Parkway
San Jose, California 95119
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San Luis Obispo, California 93401
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Santa Clara, California 95051
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600 North Cattlemen Road
Sarasota, Florida 34232
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South San Francisco, California 94080
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291 Campus Drive
Stanford, California 94305
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23929 McBean Parkway
Valencia, California 91355
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Vallejo, California 94589
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Walnut Creek, California 94596
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Westlake Village, California 91361
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