A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:January 9, 2013
End Date:December 28, 2019

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A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared
with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients
with unresectable locally advanced or metastatic melanoma, as measured by progression-free
survival (PFS), assessed by the study site investigator.


Inclusion Criteria:

- Participants with histologically confirmed melanoma, either unresectable stage IIIc or
stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th
edition. Unresectability of stage IIIc disease must have confirmation from a surgical
oncologist

- Participants must be naïve to treatment for locally advanced unresectable or
metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease;
stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed

- Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival
or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test

- Measurable disease per RECIST v1.1

- Eastern Clinical Oncology Group performance status of 0 or 1

- Consent to provide archival for biomarker analyses

- Consent to undergo tumor biopsies for biomarker analyses

- Life expectancy greater than or equal to (≥) 12 weeks

- Adequate hematologic and end organ function

Exclusion Criteria:

- History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase
pathway inhibitor treatment

- Palliative radiotherapy within 14 days prior to the first dose of study treatment

- Major surgery or traumatic injury within 14 days prior to first dose of study
treatment

- Active malignancy other than melanoma that could potentially interfere with the
interpretation of efficacy measures. Participants with a previous malignancy within
the past 3 years are excluded except for participants with resected basal cell
carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ
of the cervix, and carcinoma in-situ of the breast

- History of or evidence of retinal pathology on ophthalmological examination that is
considered a risk factor for neurosensory retinal detachment, retinal vein occlusion,
or neovascular macular degeneration

- Uncontrolled glaucoma with intraocular pressure

- Serum cholesterol ≥ Grade 2

- Hypertriglyceridemia ≥ Grade 2

- Hyperglycemia (fasting) ≥ Grade 2

- History of clinically significant cardiac dysfunction

- Participants with active central nervous system (CNS) lesions (including carcinomatous
meningitis) are excluded. However, participants are eligible if:

1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND

2. There has been no evidence of clinical and radiographic disease progression in
the CNS for ≥ 3 weeks after radiotherapy or surgery

- Current severe, uncontrolled systemic disease

- History of malabsorption or other condition that would interfere with absorption of
study drugs

- Pregnant, lactating, or breast feeding women
We found this trial at
47
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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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, 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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24 Sturtevant St
Orlando, Florida 32806
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Aurora, Colorado 80045
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Bethlehem, Pennsylvania
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100 Medical Plaza Driveway
California City, California 90095
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Camperdown, New South Wales 2050
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375 Dixmyth Ave
Cincinnati, Ohio 45220
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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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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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hayward, California 94545
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1301 Punchbowl Street
Honolulu, Hawaii 96813
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640 Eskenazi Avenue
Indianapolis, Indiana 46202
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
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La Jolla, CA
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1 Medical Center Drive
Lebanon, New Hampshire 03756
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11818 Wilshire Boulevard
Los Angeles, California 90025
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Miami Beach, Florida 33140
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Nashville, Tennessee 37203
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New York, New York 10016
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Oakland, California 94611
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Pleasant Hill, California 94523
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593 Eddy Street
Providence, Rhode Island 02903
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Roseville, California 95678
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Sacramento, California 95825
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Saint Louis, MO
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San Francisco, California 94115
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275 Hospital Parkway
San Jose, California 95119
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Santa Clara, California 95051
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3883 Airway Drive, Suite 300
Santa Rosa, California 95403
(707) 521-8830
Sutter Pacific Medical Foundation Sutter Pacific Medical Foundation doctors offer primary, specialty and complex medical...
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South San Francisco, California 94080
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975 Sereno Drive
Vallejo, California 94589
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Walnut Creek, California 94596
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Winston-Salem, North Carolina 27103
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