Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
NCT ID: NCT00769704
Last Updated: 2016-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
437 participants
INTERVENTIONAL
2009-04-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GM-CSF
Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days, followed by a 14-day rest period for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
GM-CSF
125 µg/m² subcutaneous injection
Talimogene Laherparepvec
Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
Talimogene laherparepvec
Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
Interventions
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Talimogene laherparepvec
Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
GM-CSF
125 µg/m² subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
BioVex Limited
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego, Moores Cancer Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
San Francisco Oncology Associates
San Francisco, California, United States
Northern California Melanoma Center, St. Mary's Medical Center
San Francisco, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Redwood Regional Medical Group Inc, North Bay Melanoma Program
Sebastopol, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
University of Miami
Miami, Florida, United States
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Cancer Care Center at Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Cancer Center
Kansas City, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Mountainside Hospital
Morristown, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia Medical University
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of North Carolina At Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, United States
Earle A Chiles Research Institute, Providence Cancer Center
Portland, Oregon, United States
St Luke's Hospital & Health Network
Bethlehem, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Institute for Translational Oncology Research
Greenville, South Carolina, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Texas Cancer Center, Abilene
Abilene, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
University of Texas - MD Anderson
Houston, Texas, United States
Texas Oncology, Allison Cancer Center
Midland, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, United States
Aurora/St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
GVI Oncology
Port Elizabeth, Eastern Cape, South Africa
Dr. Fourie & Bonnet
Bloemfontein, Free State, South Africa
Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa
Wits Donald Gordon Clinical Trial Site
Parktown, Guateng, South Africa
University of Pretoria
Pretoria, Guateng, South Africa
Mary Potter Oncology Centre
Pretoria, Guateng, South Africa
Hopelands Cancer Centre
Pietermaritzburg, KwaZulu-Natal, South Africa
Wilgers Oncology Center
Hatfield, Pretoria, South Africa
GVI Onocology Clinical Trials Unit
Cape Town, Western Cape, South Africa
GVI Oncology Centre
Cape Town, Western Cape, South Africa
University of Birmingham
Birmingham, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Broomfield Hospital
Chelmsford, , United Kingdom
St. James's University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St. George's University of London
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Clatterbridge Centre for Oncology
Metropolitan Borough of Wirral, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.
Andtbacka RHI, Collichio F, Harrington KJ, Middleton MR, Downey G, Ӧhrling K, Kaufman HL. Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma. J Immunother Cancer. 2019 Jun 6;7(1):145. doi: 10.1186/s40425-019-0623-z.
Kaufman HL, Andtbacka RHI, Collichio FA, Wolf M, Zhao Z, Shilkrut M, Puzanov I, Ross M. Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials. J Immunother Cancer. 2017 Sep 19;5(1):72. doi: 10.1186/s40425-017-0276-8.
Other Identifiers
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20110263
Identifier Type: OTHER
Identifier Source: secondary_id
2008-006140-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
005/05
Identifier Type: -
Identifier Source: org_study_id
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