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
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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
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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100 Medical Plaza Driveway
California City, California 90095
California City, California 90095
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
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640 Eskenazi Avenue
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
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1000 East 101st Terrace
Kansas City, Missouri 64131
Kansas City, Missouri 64131
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11818 Wilshire Boulevard
Los Angeles, California 90025
Los Angeles, California 90025
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401 East Chestnut Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
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333 East 38th Street
New York, New York 10016
New York, New York 10016
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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291 Campus Drive
Stanford, California 94305
Stanford, California 94305
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