Ovarian Cancer Clinical Trial
Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
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.
Eligibility 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
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There are 3 Locations for this study
Mineola New York, 11501, United States
New York New York, 10028, United States
Toronto Ontario, M5G 2, Canada
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