B/BE/19/BVW3 |
A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection |
Humans |
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome |
B/BE/18/BVW6 |
Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy |
Humans |
Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene |
B/BE/17/BVW2 |
A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases |
Humans |
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome |
B/BE/16/BVW1 |
A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene |
Humans |
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome |
B/BE/15/BVW2 |
A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (20130232) |
Humans |
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome |
B/BE/15/BVW1 |
A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma |
Humans |
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome |
B/BE/14/BVW1 |
A phase 2 clinical trial with Talimogene Laherparepvec |
Humans |
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome |
B/BE/11/BVW2 |
Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer |
Humans |
Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules |
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. |
A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck |
Humans |
Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. |
A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of |
Humans |
Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 09/06/1998. |
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous |
Humans |
Wild-type p53 |