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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07341360 | Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei | EARLY_PHASE1 | RECRUITING | 10 | — | — | Oct 13, 2025 | Dec 31, 2034 | Jan 14, 2026 | 1 | Norway |
Incidence of Investigative Medicinal Product-related adverse events. All ≥ Grade 3 adverse events and all grades vaccine-related adverse events will be reported and graded using CTCAE v 5.0.
Count of circulating vaccine-specific T cells
| Arm | Type | Description |
|---|---|---|
| Pseudovax peptide, adjuvant and PD-1 inhibitor | EXPERIMENTAL | Participants will be administered the Pseudovax peptide vaccine + adjuvant, granulocyte-macrophage colony-stimulating factor (GM-CSF). From study week 13, the programmed cell death 1 (PD-1) inhibitor tislelizumab will be administered in addition, for a maximum of 21 months, until confirmed progression, unacceptable toxicity, withdrawal of consent, or Investigator decision, whichever happens first. |
| Name | Type | Description |
|---|---|---|
| Pseudovax | OTHER | Pseudovax peptide dissolved in 0.5 mL water for injection to 1 mg/mL (+/- 0.1 mg/mL) |
| Molgramostim | BIOLOGICAL | Molgramostim, 100 μg recombinant human GM-CSF, powder, to be reconstituted in 0.33 mL water for injection |
| Tislelizumab | BIOLOGICAL | 100 mg of humanized IgG4 mAb in 10 mL of isotonic solution |
Inclusion Criteria: 1. The subject is ≥ 18 years of age on the day of signing the informed consent form, able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments. 2. Confirmed diagnosis of recurrent or non-res...