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4-1BB Selected TIL + IL-2 in Metastatic Melanoma
NCT02111863Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2014
- Primary completion
- Jul 2016
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Adoptive Cell Transfer
- Conditions
- melanoma
01
Overview
Phase 2, open-label, single-arm trial of 4-1BB selected tumor infiltrating lymphocytes in melanoma, sponsored by National Cancer Institute. Primary endpoints: Count of Participants With Serious and Non-Serious Adverse Events and Objective Response Rate at 2 years. Started Feb 2014; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lymphocyte Depleting Prep Regimen
Cyclophosphamide + Fludarabine -> 4-1BB Selected TIL + Aldesleukin
03
Who it enrols
Adults 18-70 with measurable metastatic melanoma who have progressed on prior systemic therapy. Must have a resectable lesion for TIL generation. Excludes patients with active infections, HIV/Hep B/C, severe cardiac disease, or need for systemic steroids.
04
Endpoints
Primary
Count of Participants With Serious and Non-Serious Adverse Events
Objective Response Rate
Secondary
Overall Survival
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