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

NCT01617629 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-12-08

Study results available
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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.

Conditions

  • Epithelial Ovarian Cancer

Interventions

BIOLOGICAL

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).

Sponsors & Collaborators

  • Prima BioMed Ltd

    lead INDUSTRY

Principal Investigators

  • Heidy Gray, MD · University of Washington

  • James Mason, MD · Scripps Cancer Center

  • Peter Eisenberg, MD · Marin Cancer Care

  • Giuseppe Del Priore, MD · Indiana University School of Medicine

  • Fernando Recio, MD · Collaborative Research Group

  • Jeffery Goh, MBBS, FRACP · Greenslopes Private Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01617629 on ClinicalTrials.gov