Epithelial Ovarian Cancer
Conditions
Keywords
Cvac
Brief summary
The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.
Interventions
BIOLOGICALMUC1 Dendritic Cell Vaccine (Cvac)
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).
Sponsors
Prima BioMed Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 available Cvac doses) * Were enrolled in CAN-003 and met protocol criteria for progressive disease * Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk * Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion * Able to provide written informed consent * White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm\^3
Exclusion criteria
* Pregnant or breastfeeding * Other medical conditions which preclude study participation, in the opinion of the investigator * Receiving treatment with any other investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | First dose of study vaccine to 30 days past last dose (Approximately 1 Year) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | Overall survival was defined as the time from randomization until death from any cause. |
Countries
Australia, United States
Participant flow
Recruitment details
Participants with ovarian cancer who participated in CAN-003 \[NCT01068509\] and had disease progression were enrolled in CAN-003x in Australia and the United States from December 2011 to April 2014.
Participants by arm
| Arm | Count |
|---|---|
| Cvac Treatment Group Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.
MUC1 Dendritic Cell Vaccine (Cvac): 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). | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Investigator's Clinical Judgement | 1 |
| Overall Study | Participant Withdrew Consent | 2 |
| Overall Study | Reason Not Specified | 1 |
Baseline characteristics
| Characteristic | Cvac Treatment Group |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized White | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 9 |
| other Total, other adverse events | 7 / 9 |
| serious Total, serious adverse events | 2 / 9 |
Outcome results
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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.
Time frame: First dose of study vaccine to 30 days past last dose (Approximately 1 Year)
Population: Safety Population included all participants who enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cvac Treatment Group | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Adverse Events | 7 participants |
| Cvac Treatment Group | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Serious Adverse Events | 2 participants |
Other Pre-specified
Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Time frame: 2 years
Population: Due to the few patients, Overall Survival could not be calculated.