Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma
NCT02297529 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2019-10-31
Summary
The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of Talimogene Laherparepvec.
Conditions
- Unresected Stage IIIB to IVM1c Melanoma
Interventions
- DRUG
-
Talimogene Laherparepvec
Open label single arm study. The initial dose of talimogene laherparepvec is up to 4.0 mL of 106 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 108 PFU/mL.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Eligibility
- Min Age
- 18 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- Switzerland
Study Locations
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