Status:
COMPLETED
Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Lead Sponsor:
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatm...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
- Complete or partial response following standard of care surgery and first line chemotherapy
- May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
- Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
- Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
- Ambulatory with an ECOG 0-1
- Life expectancy \> 6 months
- Meet protocol-specified lab requirements
- Provide informed consent and have ability to comply with protocol requirements
- Key
Exclusion
- Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
- Prior receipt of survivin based vaccines
- Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
- Progressive disease (rising CA-125 acceptable)
- More than one course of chemotherapy for recurrent disease
- Concurrent bevacizumab as maintenance therapy
- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
- History of autoimmune disease
- Recent history of thyroiditis
- Presence of a serious acute infection or chronic infection
- Brain metastases
- Other serious intercurrent chronic or acute illness
- Ongoing treatment with steroid therapy or other immunosuppressive
- Acute or chronic skin disorders
Key Trial Info
Start Date :
August 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03332576
Start Date
August 23 2013
End Date
September 9 2019
Last Update
June 18 2021
Active Locations (3)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501
2
Lenox Hill Hospital
New York, New York, United States, 10028
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9