- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03332576
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
-
-
-
-
New York
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Mineola, New York, United States, 11501
- Winthrop University Hospital
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New York, New York, United States, 10028
- Lenox Hill Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide |
PO BID
SubQ injection
|
Experimental: Cohort 2
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide |
PO BID
SubQ injection
|
Experimental: Cohort 3
3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide |
PO BID
SubQ injection
|
Experimental: Cohort 4
5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide |
PO BID
SubQ injection
|
Experimental: Cohort 5
5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide |
PO BID
SubQ injection
SubQ injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as measured by adverse event reporting (CTCAE)
Time Frame: up to 11 months
|
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
Time Frame: up to 11 months
|
up to 11 months
|
|
Impact on residual tumour
Time Frame: up to 11 months
|
Evaluated by standard of care radiology and CA-125
|
up to 11 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- ONC-DPX-Survivac-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Genentech, Inc.CompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal CancerUnited States
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Centre Oscar LambretCompleted
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University of Turin, ItalyUnknown
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