Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Vaccines

Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.

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).

MUC1 Dendritic Cell Vaccine (Cvac)

Heidy Gray, MD

James Mason, MD

Peter Eisenberg, MD

Giuseppe Del Priore, MD

Fernando Recio, MD

Jeffery Goh, MBBS, FRACP

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.

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study

An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study

Overall survival was defined as the time from randomization until death from any cause.

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.

Prima BioMed Ltd

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).

Cvac Treatment Group

Age, Continuous

Sex: Female, Male

White

Race/Ethnicity, Customized

Safety population included all participants who enrolled in the study.

Marc Voigt

Adverse Events

Serious Adverse Events

Safety Population included all participants who enrolled in the study.

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Due to the few patients, Overall Survival could not be calculated.

Overall Survival

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study	NCT01617629	Epithelial Ovar...	MUC1 Dendritic ...	18 Years -	Prima BioMed Ltd
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study	NCT01617629	Epithelial Ovar...	MUC1 Dendritic ...	18 Years -	Prima BioMed Ltd
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study	NCT01617629	Epithelial Ovar...	MUC1 Dendritic ...	18 Years -	Prima BioMed Ltd

Spots Global Cancer Trial Database for muc1 dendritic cell vaccine (cvac)