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

Completed · Phase 3

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00769704

Run by

BioVex Limited

People needed

437

Starts

2009-04-01

Expected to finish

2014-09-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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