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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02410733 | Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma | PHASE1 | COMPLETED | 119 | — | — | Mar 1, 2015 | Jun 20, 2023 | Mar 12, 2026 | 4 | Germany |
Number of patients with adverse events, total number of adverse events, dose limiting toxicities
| Arm | Type | Description |
|---|---|---|
| Lipo-MERIT | EXPERIMENTAL | 7 dose escalation cohorts (3 +3 design) and 3 expanded cohorts |
| Name | Type | Description |
|---|---|---|
| Lipo-MERIT | BIOLOGICAL | vaccination |
Inclusion Criteria: * Cohort I: stage IV malignant melanoma (American joint committee on cancer (AJCC) 2009 melanoma classification) * Cohorts II-VII and expanded cohorts: stage IIIB-C, or stage IV of malignant melanoma (AJCC 2009 melanoma classification) \[only applicable until approval of protoco...