Other
Sponsor ID
20120328

Expanded Access study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

Sponsor ID
20120328
Clinicaltrials.gov ID
NCT02297529
EUCTIS ID
N/A
EudraCT ID
2014-002834-30

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
talimogene laherparepvec (T-VEC)
Type
Expanded Access
Masking
None (Open Label)
Enrollment
125
Additional Study Details

Protocol Summary

Primary Outcome Measures

Providing expanded access of Talimogene Laherparepvec

Timeframe: 24 months

Secondary Outcome Measures

Safety and tolerability assessment

Timeframe: 24 months

Healthcare Surveillance

Timeframe: 24 months

Locations

Location
Status
Contact Us
Location
Research Site
Chur, Switzerland, 7000
Status
Recruiting
Location
Research Site
Zürich, Switzerland, 8091
Status
Recruiting
Location
Research Site
Lausanne, Switzerland, 1011
Status
Recruiting