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