Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Phase 1-2 Study 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
19
2 countries
7
Brief Summary
Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 trials. Much has been learned about the principles of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. When used alone, cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease. ImmunoVaccine Technologies Inc. (Immunovaccine) is an immuno-oncology company developing a novel adjuvanting technology platform termed DepoVax. DepoVax was created to enhance the speed, strength and duration of an immune response. The peptide antigens included in DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many cancer types, including epithelial ovarian cancers. This study was designed be a phase 1-2 trial to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. The dosing-finding phase 1 study of 15 subjects would move directly into a randomized phase 2 study. However, with the evolving field of immunotherapy Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment with checkpoint inhibitors and other immune modulators, such as in NCT02785250.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 ovarian-cancer
Started Dec 2011
Shorter than P25 for phase_1 ovarian-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedApril 21, 2017
April 1, 2017
1.4 years
August 9, 2011
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of reported adverse events
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of subcutaneous administration of DPX-Survivac.
Until 6 month follow up
Secondary Outcomes (1)
Levels of cell mediated immunity targeting the survivin epitopes
Until 6 month follow up
Study Arms (3)
Vaccine
EXPERIMENTALCohort A: 0.5 mL of DPX-Survivac (injection)
Vaccine + low dose cyclophosphamide
EXPERIMENTALCohort B: 0.1 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
Vaccine + low dose cyclophosphamide.
EXPERIMENTALCohort C: 0.5 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
Interventions
Vaccine targeting survivin antigen will be administered subcutaneously.
Low dose cyclophosphamide will be taken by mouth.
Eligibility Criteria
You may qualify if:
- Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
- Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy.
- Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac
- At least 30 days since localized surgery, radiotherapy or chemotherapy
- Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac
You may not qualify if:
- Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded
- Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
- Subjects who have received more than one course of chemotherapy for recurrent disease
- Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)
- History of autoimmune disease
- Subjects with recent history of thyroiditis
- Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis
- Subjects with brain metastases
- Concurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
- Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
- Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product
- Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A
- Allergies to any component of the vaccine
- Pregnant or nursing mothers
- Subjects with a medical or psychological impediment to probable compliance with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Berinstein NL, Karkada M, Oza AM, Odunsi K, Villella JA, Nemunaitis JJ, Morse MA, Pejovic T, Bentley J, Buyse M, Nigam R, Weir GM, MacDonald LD, Quinton T, Rajagopalan R, Sharp K, Penwell A, Sammatur L, Burzykowski T, Stanford MM, Mansour M. Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients. Oncoimmunology. 2015 May 7;4(8):e1026529. doi: 10.1080/2162402X.2015.1026529. eCollection 2015 Aug.
PMID: 26405584RESULT
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 12, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 21, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share