An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma

Completed · Phase 3

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01368276

Run by

BioVex Limited

People needed

31

Starts

2010-10-01

Expected to finish

2014-09-01

Last updated by the study team

2015-12-18

Who can join

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

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• Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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