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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00785122 | IMA910 Plus GM-CSF With Low-dose Cyclophosphamide Pre-treatment in Advanced Colorectal Carcinoma Patients Following a Successful 12 Week First-line Treatment With Oxaliplatin-based Chemotherapy (IMA910-101) | PHASE1 | COMPLETED | 92 | — | — | Jun 1, 2008 | May 1, 2013 | May 16, 2013 | 41 | Belgium, Bulgaria +7 |
Safety assessment with special emphasis on the inclusion of the first 6 patients enrolled according to a pre-specified enrolment plan
| Name | Type | Description |
|---|---|---|
| Endoxana, Leukine, IMA910 | DRUG | a single i.v. infusion of 300 mg/m2 Endoxana (Cyclophosphamide) and then 3 days later (visit 1) patients will start vaccination therapy with intradermal (i.d.) injections of 75µg GM-CSF followed by i.d. injections of 5.78 mg IMA90 |
| Endoxana, Leukine, IMA910, Aldara | DRUG | a single i.v. infusion of 300 mg/m2 Endoxana (Cyclophosphamide) and then 3 days later (visit 1) patients will start vaccination therapy with intradermal (i.d.) injections of 75µg GM-CSF followed by i.d. injections of 5.78 mg IMA90 followed by Aldara (Imiquimod) |
Inclusion criteria: * Aged at least 18 years * HLA type: HLA-A\*02-positive * Histologically confirmed colorectal adenocarcinoma (CRC) * Radiological evidence (CT/MRI) of unresectable locally advanced and/or metastatic CRC prior to 12 week first-line oxaliplatin-based standard chemotherapy * 12 wee...