Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Conditions
Keywords
vaccine, immunotherapy, combination therapy
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 treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.
Interventions
BIOLOGICALDPX-Survivac
SubQ injection
BIOLOGICALDPX-Survivac(Aqueous)
SubQ injection
DRUGCyclophosphamide
PO BID
Sponsors
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by adverse event reporting (CTCAE) | up to 11 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cell mediated immunity as measured by the antigen specific response in peripheral blood | up to 11 months | — |
| Impact on residual tumour | up to 11 months | Evaluated by standard of care radiology and CA-125 |
Countries
Canada, United States
Outcome results
None listed