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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01617629 | Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study | PHASE2 | COMPLETED | 9 | — | — | Dec 1, 2011 | Apr 1, 2014 | Dec 8, 2017 | 6 | United States, Australia |
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Cvac Treatment Group | EXPERIMENTAL | Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment. |
| Name | Type | Description |
|---|---|---|
| MUC1 Dendritic Cell Vaccine (Cvac) | BIOLOGICAL | The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac). Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks). |
Inclusion Criteria: * Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003 * Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have ...