Unresected Stage IIIB to IVM1c Melanoma Clinical Trial
Official title:
A Phase 3b, Multicenter, Open-label, Single-arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects in Europe With Unresected Stage IIIB to IVM1c Melanoma
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.
This is a phase 3b, multicenter, open-label, single-arm, expanded access study of talimogene laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma in select European countries. Subjects with unresected stage lllB-IVM1c melanoma who are not eligible for or cannot access ongoing talimogene laherparepvec clinical trials and who meet the eligibility criteria outlined will be considered for participation in this protocol. Eligible subjects will be treated with talimogene laherparepvec until the subject has achieved a complete response, all injectable tumors have disappeared, clinically relevant (resulting in clinical deterioration or requiring change of therapy) disease progression beyond 6 months of therapy, intolerance of protocol treatment, or until talimogene laherparepvec receives marketing authorization approval in Europe for the treatment of melanoma, whichever occurs first. Subjects will be followed for safety approximately 30 (+7) days after the end of treatment. Thereafter, subjects who provide consent will be followed under an ongoing separate registry protocol for the long-term survival follow-up of subjects treated with talimogene laherparepvec in clinical trials. The registry protocol will also monitor for late and long-term adverse events thought to be potentially related to talimogene laherparepvec. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02366195 -
Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
|
Phase 2 | |
| No longer available |
NCT02147951 -
Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma
|
Phase 3 |