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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01684241 | RBL001/RBL002 Phase I Clinical Trial | PHASE1 | COMPLETED | 29 | — | — | Jun 1, 2012 | Jul 1, 2015 | Jan 18, 2020 | 4 | Austria, Germany |
Number of Patients with adverse events, total number of adverse events, dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| RBL001/RBL002 intranodal administration | EXPERIMENTAL | All participants will be treated with RBL001/RBL002 after allocation to one of the four escalating dose cohorts: * Cohort-1 50 µg RBL001 and 50 µg RBL002 * Cohort-2 100 µg RBL001 and 100 µg RBL002 * Cohort-3 300 µg RBL001 and 300 µg RBL002 * Cohort-4 600 µg RBL001 and 600 µg RBL002 |
| Name | Type | Description |
|---|---|---|
| RBL001/RBL002 | BIOLOGICAL | Each participant will receive 8 repeated intranodal administrations of RBL001 and RBL002 during a time frame of 43 to 51 days. |
Inclusion Criteria: * Stage IIC, IIIA-C or unresectable stage IV of cutaneous melanoma (AJCC 2009 melanoma classification) * First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented...