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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05743595 | Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma | PHASE1 | ACTIVE NOT_RECRUITING | 27 | — | — | Oct 27, 2023 | Mar 9, 2029 | May 4, 2026 | 1 | United States |
* Safety will be defined as a \< 33% treatment-related DLT rate related to vaccination alone or in combination with retifanlimab, by the end of the DLT observation period for a given cohort. * A DLT will be defined as any grade 3 toxicity or greater according to CTCAE v5 considered at least possibly related to study treatment (exceptions are listed in the protocol). * The DLT observation period begins with date of first vaccine administration and continues for 30 days from administration of first dose of retifanlimab. For patients in Cohort A, this is Day 87 (first dose of retifanlimab is given with vaccine Dose 3 on Day 57), and for patients in Cohort B, this is Day 30 (first dose of retifanlimab is given with vaccine Dose 1 on Day 1).
| Arm | Type | Description |
|---|---|---|
| Cohort A: Personalized neoantigen DNA vaccine + retifanlimab | EXPERIMENTAL | * Cohort A will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection alone during the first two priming doses, then concurrently with retifanlimab during the subsequent boosting doses (Doses 3 through 6) * The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days. * Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab |
| Cohort B: Personalized neoantigen DNA vaccine + retifanlimab | EXPERIMENTAL | * Cohort B will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection plus concurrent retifanlimab beginning with Dose 1 and continuing for a total of 6 doses. * The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days. * Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab |
| Name | Type | Description |
|---|---|---|
| Personalized Neoantigen DNA vaccine | BIOLOGICAL | The sites of immunization may be rotated for each of the immunizations. |
| Retifanlimab | BIOLOGICAL | Retifanlimab will be supplied by Incyte. |
| TDS-IM v 2.0 electroporation device | DEVICE | Each DNA vaccination will be 1 mL vaccine administered intramuscularly using an integrated electroporation administration system |
Step 1 Inclusion Criteria for Tissue Sequencing: * Newly diagnosed histologically or molecularly consistent with WHO grade IV high grade glioma, IDH wildtype. * Patients who had prior craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted. * Consent to ...