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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously
Low dose cyclophosphamide will be taken by mouth
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada
Objective response rate
Time frame: approximately 6 months
Immune response
levels of cell mediated immunity targeting the survivin epitopes
Time frame: 1 year
Frequency of adverse events
Time frame: 1 year
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