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

Use our guide to learn which trials are right for you!

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
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
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...
1777
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
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...
1762
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
Aurora, Colorado 80045
820
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
2035 Paraguay
Buenos Aires, C1121
6112
mi
from 91732
Buenos Aires,
Click here to add this to my saved trials
100 Medical Plaza Driveway
California City, California 90095
24
mi
from 91732
California City, CA
Click here to add this to my saved trials
86 Jonathan Lucas Street
Charleston, South Carolina 29425
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Durham, North Carolina 27710
2199
mi
from 91732
Durham, NC
Click here to add this to my saved trials
Fort Myers, Florida 33905
2203
mi
from 91732
Fort Myers, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
1819
mi
from 91732
Goshen, IN
Click here to add this to my saved trials
Grand Junction, Colorado 81501
627
mi
from 91732
Grand Junction, CO
Click here to add this to my saved trials
Hayward, California 94545
337
mi
from 91732
Hayward, CA
Click here to add this to my saved trials
Hollywood, Florida
2317
mi
from 91732
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
640 Eskenazi Avenue
Indianapolis, Indiana 46202
1791
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Irvine, California 92604
29
mi
from 91732
Irvine, CA
Click here to add this to my saved trials
Kansas City, Missouri 64111
1340
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
1000 East 101st Terrace
Kansas City, Missouri 64131
1340
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92093
99
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
11818 Wilshire Boulevard
Los Angeles, California 90025
25
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1813
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
Morgantown, West Virginia 26506
2122
mi
from 91732
Morgantown, WV
Click here to add this to my saved trials
300 20th Avenue North
Nashville, Tennessee 37203
1762
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
333 East 38th Street
New York, New York 10016
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
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...
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
3600 Broadway
Oakland, California 94611
351
mi
from 91732
Oakland, CA
Click here to add this to my saved trials
Oakland, California 94611
349
mi
from 91732
Oakland, CA
Click here to add this to my saved trials
Park Ridge, Illinois 60068
1720
mi
from 91732
Park Ridge, IL
Click here to add this to my saved trials
625 South Fair Oaks Avenue
Pasadena, California 91105
8
mi
from 91732
Pasadena, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
100 Madison Avenue
Randolph, New Jersey 07869
2408
mi
from 91732
Randolph, NJ
Click here to add this to my saved trials
Roseville, California 95678
370
mi
from 91732
Roseville, CA
Click here to add this to my saved trials
Sacramento, California 95825
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
1569
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94115
356
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials
275 Hospital Parkway
San Jose, California 95119
305
mi
from 91732
San Jose, CA
Click here to add this to my saved trials
San Luis Obispo, California 93401
172
mi
from 91732
San Luis Obispo, CA
Click here to add this to my saved trials
Santa Clara, California 95051
316
mi
from 91732
Santa Clara, CA
Click here to add this to my saved trials
600 North Cattlemen Road
Sarasota, Florida 34232
2151
mi
from 91732
Sarasota, FL
Click here to add this to my saved trials
South San Francisco, California 94080
349
mi
from 91732
South San Francisco, CA
Click here to add this to my saved trials
291 Campus Drive
Stanford, California 94305
329
mi
from 91732
Stanford, CA
Click here to add this to my saved trials
23929 McBean Parkway
Valencia, California 91355
38
mi
from 91732
Valencia, CA
Click here to add this to my saved trials
Vallejo, California 94589
367
mi
from 91732
Vallejo, CA
Click here to add this to my saved trials
Walnut Creek, California 94596
347
mi
from 91732
Walnut Creek, CA
Click here to add this to my saved trials
Westlake Village, California 91361
45
mi
from 91732
Westlake Village, CA
Click here to add this to my saved trials