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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02316457 | RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID | PHASE1 | COMPLETED | 42 | — | — | Oct 1, 2016 | May 17, 2023 | Mar 13, 2026 | 4 | Germany, Sweden |
Assessment of AEs
Assessment of AEs, End of treatment visit is depending on treatment schedule
| Arm | Type | Description |
|---|---|---|
| ARM1 IVAC_W_bre1_uID | EXPERIMENTAL | Patients enrolled in ARM1 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient. |
| ARM2 IVAC_W_bre1_uID/IVAC_M_uID | EXPERIMENTAL | Patients enrolled in ARM2 will optionally receive the WAREHOUSE treatment as described above followed by the personalized IVAC® MUTANOME immunotherapy. The mutation selection process constitutes a multi-step process including identification of somatic mutations by NGS, mutation confirmation and prioritization, selection, and on demand manufacturing. |
| ARM3 IVAC_W_bre1_uID + RBLTet.1 | EXPERIMENTAL | Patients enrolled in ARM3 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient. RBLTet.1 RNA will be added to each RNA applied. |
| Name | Type | Description |
|---|---|---|
| IVAC_W_bre1_uID | BIOLOGICAL | vaccination |
| IVAC_W_bre1_uID/IVAC_M_uID | BIOLOGICAL | vaccination |
Inclusion Criteria: * Histologically confirmed invasive adenocarcinoma triple negative breast cancer (TNBC), pT1cN0M0 - anyTanyNM0 confirmed by physical examination or imaging * Triple negative breast cancer was defined as: * HER2 negative * IHC 0-1+ * IHC 2+ and FISH negative (ratio \< 2.0 ...