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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02035956 | IVAC MUTANOME Phase I Clinical Trial | PHASE1 | COMPLETED | 15 | — | — | Dec 1, 2013 | Oct 1, 2019 | Jan 18, 2020 | 3 | Austria, Germany |
Number of Patients with adverse events, total number of adverse events
| Arm | Type | Description |
|---|---|---|
| IVAC MUTANOME RBL001/RBL002 | EXPERIMENTAL | All participants will be treated with the personalized IVAC MUTANOME vaccine with or without prior treatment with RBL001/RBL002 vaccine depending on expression of these two antigens. Vaccines will be administered intra-nodally. |
| Name | Type | Description |
|---|---|---|
| IVAC MUTANOME, RBL001/RBL002 | BIOLOGICAL | Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002. |
Inclusion Criteria: * Malignant Melanoma, resectable stage IIIA-C and IV (AJCC 2009 melanoma classification) * Patients with unresectable Malignant Melanoma stage IIIA-C in complete remission, partial remission or stable disease after treatment with vemurafenib or patients with slow progressive dis...