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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03219450 | A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL. | PHASE1 | RECRUITING | 15 | — | — | Aug 18, 2021 | Jul 31, 2028 | May 28, 2026 | 1 | United States |
The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production
Of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks
The number of patients with treatment-limiting toxicities based on NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| NeoVax | EXPERIMENTAL | * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. |
| Neovax + Low-dose cyclophosphamide | EXPERIMENTAL | * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 |
| Neovax + Low-dose cyclophosphamide + Pembrolizumab | EXPERIMENTAL | * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 * Pembrolizumab will be administered starting on Week 12 Day 78 and for up to 17 cycles (approximately 1 year). |
| Name | Type | Description |
|---|---|---|
| NeoVax | DRUG | It stimulates the immune system to attack cancer cells. |
| Cyclophosphamide | DRUG | It is a chemotherapy drug used to treat many cancers. At low doses, it is an investigational drug to help the immune cells to be better at attacking cancer cells while avoiding chemotherapy toxicity. |
| Pembrolizumab | DRUG | Is a monoclonal antibody that helps the immune cells to be better at attacking cancer cells. |
Inclusion Criteria: * Diagnosis of CLL as per IWCLL 2018 criteria * Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as \< 2% mutated compared to germline. * Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criter...