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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00523159 | IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease | PHASE2 | COMPLETED | 68 | — | — | May 1, 2007 | Aug 1, 2009 | Jul 10, 2012 | 44 | Austria, Bulgaria +8 |
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | Pre-treatment with a single low dose of Cyclophosphamide followed by IMA901 vaccination plus GM-CSF as adjuvant |
| 2 | OTHER | No pre-treatment with Cyclophosphamide before vaccination with IMA901 and GM-CSF as adjuvant |
| Name | Type | Description |
|---|---|---|
| Endoxana, IMA901, Leukine | DRUG | a single i.v. infusion of Cyclophosphamid and then patients received vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901 |
| IMA901 and Leukine | DRUG | Intradermal injection of GM-CSF followed by intradermal injection of IMA901 |
Inclusion Criteria: * Aged at least 18 years * HLA type: HLA-A\*02-positive * Histologically documented advanced clear-cell RCC * Patients who have received first-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease systematic therapy for advanced disease and must be can...