A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy

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Study title: 
A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy
Long title: 
A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy
Date receipt dossier: 
4 oct 2018
EudraCT number: 
2018-000824-32
Company / Sponsor: 
Immune Design
Phase: 
III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Synovial sarcomas
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen
Method of transfer of nucleic acid of interest: 
not applicable
Administered biological material: 
Recombinant replication defective lentiviral vector (LV305)
Route of administration: 
Subcutaneous
Locations in Belgium: 
UZ Leuven
Type of procedure: 
Contained use only
Current status: 
Under evaluation