Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03548467 | A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer | PHASE1 | COMPLETED | 41 | — | — | Apr 4, 2018 | Jan 30, 2023 | Apr 21, 2023 | 6 | Germany |
Total number, severity (CTCAE grade) of adverse events (AEs), and if AE is leading to treatment discontinuation.
| Arm | Type | Description |
|---|---|---|
| VB10.NEO intervention | EXPERIMENTAL | Treatment with individualized VB10.NEO immunotherapy will commence as soon as the patient-specific VB10.NEO vaccine is available and if the patient-specific vaccine meets all pre-specified product release criteria after manufacturing to patients within the selected tumor types. |
| VB10.NEO in combination with bempegaldesleukin (NKTR-214) | EXPERIMENTAL | Bempegaldesleukin (NKTR-214) will be given in combination with VB10.NEO in up to 10 patients with SCCHN. Treatment with individualized VB10.NEO immunotherapy will commence as soon as the patient-specific VB10.NEO vaccine is available and if the patient-specific vaccine meets all pre-specified product release criteria after manufacturing. Bempegaldesleukin (NKTR-214) will be given after at least 4 doses of VB10.NEO. |
| Name | Type | Description |
|---|---|---|
| VB10.NEO | BIOLOGICAL | VB10.NEO is a vaccine and is supplied as a sterile, ready to use solution (14 vaccinations will be given). |
| Bempegaldesleukin | DRUG | 0.006 mg/kg bempegaldesleukin (NKTR-214) will be administered intravenously q4w for up to 11 doses starting from week 11 or at any dosing visit up to week 34 and for up to week 50 (up to 11 doses). The first 2 doses will be in a Q3W interval and following doses in Q4W intervals. |
Inclusion criteria for all arms * Have histologically confirmed locally advanced or metastatic melanoma, NSCLC, RCC, urothelial carcinoma or SCCHN. * Patients must have been on CPI (i.e., anti-PD-1 or anti PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their c...