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

Phase 2

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Biological: MUC1 Dendritic Cell Vaccine (Cvac)

• Registration Number: NCT01617629
• Lead Sponsor: Prima BioMed Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-11
• Results First Submitted: 2017-11-10
• Results First Submitted QC: 2017-11-10
• Last Update Submitted: 2017-11-10
• Results First Posted: 2017-12-08
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Marin Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Collaborative Research Group; 🇺🇸 Boca Raton, Florida, United States

Scripps Cancer Center; 🇺🇸 La Jolla, California, United States

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Queensland, Australia

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States