Phase 2 N=9 Treatment

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

Epithelial Ovarian Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01617629 ↗

Enrolled (actual)

Serious AEs

22.2%

Results posted

Dec 2017

Primary outcome: Primary: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) — 7; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MUC1 Dendritic Cell Vaccine (Cvac) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Prima BioMed Ltd
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	7; 2	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01617629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.