Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer.

Conditions
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Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Intervention / Treatment
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* Biological: DPX-Survivac
* Biological: DPX-Survivac(Aqueous)
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide | Biological: DPX-Survivac<br>* SubQ injection<br>Drug: Cyclophosphamide<br>* PO BID<br>|
| Experimental: Cohort 2<br>6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide | Biological: DPX-Survivac<br>* SubQ injection<br>Drug: Cyclophosphamide<br>* PO BID<br>|
| Experimental: Cohort 3<br>3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide | Biological: DPX-Survivac<br>* SubQ injection<br>Drug: Cyclophosphamide<br>* PO BID<br>|
| Experimental: Cohort 4<br>5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide | Biological: DPX-Survivac<br>* SubQ injection<br>Drug: Cyclophosphamide<br>* PO BID<br>|
| Experimental: Cohort 5<br>5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide | Biological: DPX-Survivac<br>* SubQ injection<br>Biological: DPX-Survivac(Aqueous)<br>* SubQ injection<br>Drug: Cyclophosphamide<br>* PO BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse event reporting (CTCAE) |  | up to 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell mediated immunity as measured by the antigen specific response in peripheral blood |  | up to 11 months | 
| Impact on residual tumour | Evaluated by standard of care radiology and CA-125 | up to 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, immunotherapy, combination therapy