Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Anti-MART-1 F5 TCR-Engineered Lymphocytes and ALVAC Vaccine in Metastatic Melanoma
NCT00612222Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2008
- Primary completion
- Mar 2011
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Viral Vector Vaccines, TCR-Engineered T Cells
01
Overview
Phase 2, open-label, single-arm trial of autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes and ALVAC-MART-1 in melanoma, sponsored by National Cancer Institute. Primary endpoint: Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR). Started Jan 2008; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
ALVAC plus anti-MART-1 F5 TCR PBL + HD IL-2
Conditioning followed by ALVAC vaccine, TCR-engineered PBL infusion, and high-dose IL-2.
03
Who it enrols
Patients 18+ with metastatic melanoma who are HLA-A*0201 positive and MART-1 positive, and have failed prior high-dose IL-2 therapy.
04
Endpoints
Primary
Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)
Secondary
Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells
Number of Participants With Adverse Events
Beyond the preview
Go deeper on NCT00612222.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00612222.