Trial Outcomes & Findings for Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (NCT NCT01617629)
NCT ID: NCT01617629
Last Updated: 2017-12-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
First dose of study vaccine to 30 days past last dose (Approximately 1 Year)
Results posted on
2017-12-08
Participant Flow
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.
Participant milestones
| Measure |
Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (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).
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (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).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Investigator's Clinical Judgement
|
1
|
|
Overall Study
Reason Not Specified
|
1
|
|
Overall Study
Participant Withdrew Consent
|
2
|
Baseline Characteristics
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Baseline characteristics by cohort
| Measure |
Cvac Treatment Group
n=9 Participants
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).
|
|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cvac Treatment Group
n=9 Participants
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).
|
|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse Events
|
7 participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Serious Adverse Events
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Due to the few patients, Overall Survival could not be calculated.
Overall survival was defined as the time from randomization until death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
Cvac Treatment Group
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cvac Treatment Group
n=9 participants at risk
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).
|
|---|---|
|
General disorders
Incarcerated hernia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Injury, poisoning and procedural complications
Wound complication
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
General disorders
Disease progression
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
Other adverse events
| Measure |
Cvac Treatment Group
n=9 participants at risk
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).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
22.2%
2/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
2/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Eye disorders
Blepharospasm
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Abdominal hernia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Gastrointestinal disorders
Umbilical hernia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
General disorders
Chills
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
General disorders
Fatigue
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
General disorders
Injection site pruritus
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Infections and infestations
Ear infection
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Infections and infestations
Gastric infection
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Infections and infestations
Rash pustular
|
22.2%
2/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Restless legs syndrome
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Nervous system disorders
Sciatica
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Psychiatric disorders
Abnormal dreams
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
2/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For study centers in Australia, no publication of the study results may be made until publication of the results of the study from all centers or until 2 years after study completion, whichever is sooner. For study centers in the USA, no submission for publication or public disclosure of the results by will be made until the results from all centers have been received and analyzed by the sponsor, or the multi-center study has been terminated or abandoned at all centers.
- Publication restrictions are in place
Restriction type: OTHER