Phase 2
Completed N=9
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Source: ClinicalTrials.gov NCT01617629 ↗Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) — 7; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
7; 2 | — |
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
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. Informational only — not medical advice.