An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
NCT ID: NCT01368276
Last Updated: 2015-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2010-10-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
125 µg/m² subcutaneous injection
Talimogene Laherparepvec
Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
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
Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
125 µg/m² subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. received the maximum number of talimogene laherparepvec treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or
2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05. New injectable lesions must have appeared within ≤ 12 months from the End of Treatment visit on the 005/05 study.
2. In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted \[e.g., those patients who do not have clinically relevant progressive disease (PDr)\].
3. Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1.
4. For patients randomized to talimogene laherparepvec only: Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.
Exclusion Criteria
2. History of Grade 3 fatigue lasting \> 1 week while on talimogene laherparepvec treatment.
3. History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.
4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other talimogene laherparepvec related non-hematological toxicities while on talimogene laherparepvec treatment that required a dose delay or discontinuation of talimogene laherparepvec therapy.
5. PDr while participating in study 005/05
6. Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
7. At the discretion of the investigator, patient was withdrawn from the 005/05 trial.
18 Years
ALL
No
Sponsors
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BioVex Limited
INDUSTRY
Responsible Party
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Locations
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Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, United States
University of North Carolina At Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, United States
Royal Marsden Hospital
London, , United Kingdom
Countries
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Related Links
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Sponsor Website
Other Identifiers
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2010-021070-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110279
Identifier Type: OTHER
Identifier Source: secondary_id
005/05-E
Identifier Type: -
Identifier Source: org_study_id