Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2009
End Date:September 2014

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A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

The objective of this study is to evaluate the efficacy and safety of treatment with
talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with
unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim
to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec
as compared to GM-CSF.


Inclusion Criteria:

- Males or females age ≥ 18 years

- Stage IIIb, IIIc or stage IV disease that is not surgically resectable

- Injectable disease (i.e. suitable for direct injection or through the use of
ultrasound guidance)

- At least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >= 10 mm in
longest diameter or, multiple injectable melanoma lesions which in aggregate have a
longest diameter of >= 10 mm

- Serum lactate dehydrogenase (LDH) levels less than 1.5 x upper limit of normal (ULN)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Prolongation in International Normalized Ratio (INR), Prothrombin Time (PT), and
Partial Thromboplastin Time (PTT) when the result is from therapeutic anticoagulation
treatment are permitted for patients whose injectable lesions are cutaneous and/or
subcutaneous such that direct pressure could be applied in the event of excessive
bleeding

Exclusion Criteria:

- Clinically active cerebral or any bone metastases. Patients with up to 3
(neurological performance status of 0) cerebral metastases may be enrolled, provided
that all lesions have been adequately treated with stereotactic radiation therapy,
craniotomy, gammaknife therapy, with no evidence of progression, and have not
required steroids, for at least two (2) months prior to randomization

- Greater than 3 visceral metastases (this does not include lung metastases or nodal
metastases associated with visceral organs). For patients with < 3 visceral
metastases, no lesion > 3 cm, and liver lesions must meet Response Evaluation
Criteria In Solid Tumors (RECIST) criteria for stable disease for at least 1 month
prior to randomization
We found this trial at
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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3525
Lakeland, Florida 33805
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
334
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
795
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
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Abilene, Texas 79701
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Albuquerque, New Mexico 87109
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Aurora, Colorado 80045
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45267
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Edmonton, Alberta
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Greenville, South Carolina 29605
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Indianapolis, Indiana 46254
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Jacksonville, Florida
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Kansas City, Missouri 66210
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La Jolla, CA
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757 Westwood Plaza
Los Angeles, California 90024
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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Miami Beach, Florida 33140
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Morristown, New Jersey 07962
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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New York, New York 10032
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8303 Dodge St
Omaha, Nebraska 68114
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Methodist Estabrook Cancer Center At Methodist Estabrook Cancer Center, we understand how deeply a diagnosis...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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Robbinsdale, Minnesota 55422
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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