An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment With OncoVEX^GM-CSF for Eligible Melanoma Patients Participating in Study 005/05
3 other identifiers
interventional
31
2 countries
10
Brief Summary
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2010
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
December 18, 2015
CompletedDecember 18, 2015
November 1, 2015
3.9 years
April 20, 2011
September 22, 2015
November 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (AEs)
AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE. Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator. A serious AE is one that meets one or more of the following criteria/outcomes: * Results in death. * Is life-threatening. * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Is a congenital anomaly/birth defect. * Is an important medical event.
From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.
Secondary Outcomes (2)
Objective Response Rate
From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.
Durable Response Rate
From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.
Study Arms (2)
GM-CSF
ACTIVE COMPARATORGranulocyte 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.
Talimogene Laherparepvec
EXPERIMENTALTalimogene 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.
Interventions
Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
Eligibility Criteria
You may qualify if:
- Previously participated in protocol 005/05 (NCT00769704) and:
- received the maximum number of talimogene laherparepvec treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or
- 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.
- In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted \[e.g., those patients who do not have clinically relevant progressive disease (PDr)\].
- Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or 1.
- 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.
You may not qualify if:
- Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity related to talimogene laherparepvec of any organ system (with the exception of injection site reactions, fever and vomiting).
- History of Grade 3 fatigue lasting \> 1 week while on talimogene laherparepvec treatment.
- History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.
- 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.
- PDr while participating in study 005/05
- Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
- At the discretion of the investigator, patient was withdrawn from the 005/05 trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioVex Limitedlead
Study Sites (10)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
University of North Carolina At Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2011
First Posted
June 7, 2011
Study Start
October 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 18, 2015
Results First Posted
December 18, 2015
Record last verified: 2015-11