Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
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.
1 other identifier
interventional
37
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2013
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2016
CompletedFirst Submitted
Initial submission to the registry
November 2, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2019
CompletedJune 18, 2021
June 1, 2021
3 years
November 2, 2017
June 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as measured by adverse event reporting (CTCAE)
up to 11 months
Secondary Outcomes (2)
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
Study Arms (5)
Cohort 1
EXPERIMENTAL6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Cohort 2
EXPERIMENTAL6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Cohort 3
EXPERIMENTAL3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide
Cohort 4
EXPERIMENTAL5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide
Cohort 5
EXPERIMENTAL5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Winthrop University Hospital
Mineola, New York, 11501, United States
Lenox Hill Hospital
New York, New York, 10028, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2017
First Posted
November 6, 2017
Study Start
August 23, 2013
Primary Completion
September 8, 2016
Study Completion
September 9, 2019
Last Updated
June 18, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share