Clinical trial NCT01368276: An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Keywords: Melanoma
Stage IIIb, IIIc and IV Disease
oncolytic
OncoVex
OncoVEX^GM-CSF
Lead sponsor: BioVex Limited
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Previously participated in protocol 005/05 (NCT00769704) and:

   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:

1. 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).
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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: 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:
measure: Objective Response Rate
timeFrame: 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.
measure: Durable Response Rate
timeFrame: 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.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Robbinsdale
country: United States
facility: Hubert H Humphrey Cancer Center
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina At Chapel Hill School of Medicine
state: North Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salem
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: London
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
References: