Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MUC1 Dendritic Cell Vaccine (Cvac)
MUC1 Dendritic Cell Vaccine · 1 trial · 1 indication
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 ...
MUC1 Dendritic Cell Vaccine (Cvac) is an investigational immunotherapy studied in epithelial ovarian cancer. It was evaluated in a Phase 2 trial for patients whose disease had progressed during the CAN-003 study. It is a vaccine modality being developed by Immutep Limited and is not an approved therapy.
MUC1 Dendritic Cell Vaccine (Cvac) is being developed by Immutep Limited, which trades under the ticker IMMP. The company is the sponsor of the clinical program for this ovarian cancer vaccine candidate.
MUC1 Dendritic Cell Vaccine (Cvac) is in Phase 2 development. The program includes one completed Phase 2 trial in epithelial ovarian cancer. It is an investigational product and has not been approved by the FDA for any indication.
MUC1 Dendritic Cell Vaccine (Cvac) was studied in the completed Phase 2 trial NCT01617629, titled Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study. The trial enrolled 9 female patients aged 18 years and older in the United States and Australia.
Yes. MUC1 Dendritic Cell Vaccine is also known as MUC1 Dendritic Cell Vaccine (Cvac), or simply Cvac. Both names refer to the same investigational immunotherapy developed by Immutep Limited for epithelial ovarian cancer.