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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07347210 | Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma | PHASE2 | NOT YET_RECRUITING | 98 | — | — | Jan 1, 2026 | Jul 1, 2029 | Jan 16, 2026 | 4 | France |
Rate for patients alive at 18 months post-randomization
| Arm | Type | Description |
|---|---|---|
| Experimental Arm A | EXPERIMENTAL | UCPVax + Pembrolizumab + Standard of care |
| Experimental Arm B | EXPERIMENTAL | UCPVax + Standard of care |
| Control Arm C | OTHER | Standard of care |
| Name | Type | Description |
|---|---|---|
| UCPVax | DRUG | Priming : UCPVax (two helper peptides UCP2 and UCP4 + Montanide ISA51) at 0.5 mg subcutaneously at day 1, 8, 15, 29, 36 and 43 Boost : UCPVax at 0.5 mg subcutaneously one month after priming and then every 8 weeks for 12 months maximum |
| Pembrolizumab | DRUG | 400 mg/m1 every 6 weeks since day 1 until disease progression or unacceptable toxicity for a maximum of 1 year |
| Temozolomide | DRUG | 150-200 mg/m2/day x 5 days per month x 6 months according to best standard of care starting at day 1 of week 1 (with vaccine 1 of UCPVax). Additional treatment with NOVO-TTF200A will be allowed. |
Inclusion Criteria: 1. Male or female, age ≥ 18 with informed consent signed 2. Patient with a confirmed histological diagnosis of non-mutated IDH primary glioblastoma (surgical resection or biopsy). 3. Tumor with unmethylated MGMT promoter status 4. Patients having completed the concomitant phase ...