- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02323230
A Study of DPX-Survivac Vaccine Therapy in Patients With Recurrent Survivin-expressing DLBCL
June 16, 2021 updated by: ImmunoVaccine Technologies, Inc. (IMV Inc.)
Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Recurrent Survivin-Expressing Diffuse Large B-Cell Lymphoma (DLBCL)
This phase 2 study was designed to assess the efficacy and safety of DPX-Survivac plus low dose cyclophosphamide in up to 24 subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant.
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.
This phase 2 study was therefore terminated with fewer subjects than planned to allow the progress of other studies, such as NCT03349450.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
A multi-center treatment study assessing the efficacy and safety of an immunotherapeutic vaccine (DPX-Survivac) combined with low dose cyclophosphamide.
Subjects with measurable, histologically proven DLBCL expressing survivin will be treated in this open-label, single arm study.
Survivin is a protein commonly over-expressed in many types of cancer, including DLBCL.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre, Odette Cancer Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Subjects with histologically proven recurrent DLBCL. Subjects may have recurrence after primary or second treatment regimens for DLBCL. Subjects with recurrence at least 90 days post-autologous stem cell transplantation (ASCT) are eligible. Patients with partial response or measurable disease after first line therapy (who are not candidates for ASCT) or after second line therapy without disease progression may also be eligible.
- Previous localized surgery, radiotherapy, and chemotherapy more than 21 days prior to SD0.
- Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy (e.g. rituximab), other B cell depleting antibody therapy, or radioimmunotherapy (e.g. tositumomab or ibritumomab) if last administration is greater than 77 days prior to SD0.
- Subjects must have at least one measurable site of disease.
- Willing to undergo a pre-treatment and post-treatment tumor biopsy.
- Subjects must have evidence of survivin expression in pre-treatment tumor sample.
- A screening Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.
- A life expectancy > 6 months.
Main Exclusion Criteria:
- Patients eligible for possible curative therapies such as ASCT.
- Patients undergoing concurrent chemotherapy, radiation therapy, or immunotherapy or who are currently on an investigational product/trial are excluded. There must be at least 21 days since completion of prior chemotherapy/radiation and at least 77 days since completion of immunotherapy until study treatment begins (SD0). Subjects must have recovered from all acute toxicities from prior treatment; peripheral neuropathy must be < grade 2.
- Lactate dehydrogenase (LDH) greater than 2 times the upper limit of normal.
- Patients with refractory disease after their last treatment (i.e. progression within 90 days).
- Patients who have received prior survivin based vaccines.
- Progressive CNS lymphoma requiring treatment within 84 days prior to SD0.
- History of active autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DPX-Survivac + low dose cyclophosphamide
|
Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously
Low dose cyclophosphamide will be taken by mouth
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate
Time Frame: approximately 6 months
|
approximately 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune response
Time Frame: 1 year
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levels of cell mediated immunity targeting the survivin epitopes
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1 year
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Frequency of adverse events
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
December 12, 2014
First Submitted That Met QC Criteria
December 17, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Actual)
June 22, 2021
Last Update Submitted That Met QC Criteria
June 16, 2021
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- 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-05
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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