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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01265901 | IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma | PHASE3 | COMPLETED | 339 | — | — | Dec 1, 2010 | Jul 1, 2015 | Oct 12, 2017 | 105 | United States, France +9 |
| Arm | Type | Description |
|---|---|---|
| Sunitinib | ACTIVE_COMPARATOR | Sunitib as Standard therapy per Label. |
| IMA901 plus GM-CSF added to sunitinib after single dose of cy | EXPERIMENTAL | After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib |
| Name | Type | Description |
|---|---|---|
| Sunitinib | DRUG | As per label. |
| GM-CSF | BIOLOGICAL | Intradermal injection of GM-CSF as adjuvant. |
| Cyclophosphamide | DRUG | One single low-dose i.v. infusion prior to the first vaccination |
| IMA901 | DRUG | Intradermal vaccinations with IMA901 vaccine. |
Inclusion Criteria: 1. Aged at least 18 years. 2. HLA type: HLA-A\*02-positive 3. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required. 4. Measurable and/or non-measurable tumor lesions as...