Status:
COMPLETED
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
Lead Sponsor:
BioVex Limited
Collaborating Sponsors:
Amgen
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00769704
Start Date
April 1 2009
End Date
September 1 2014
Last Update
July 13 2016
Active Locations (83)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
University of California San Diego, Moores Cancer Center
La Jolla, California, United States, 92093
4
UCLA Medical Center
Los Angeles, California, United States, 90095