This is a Phase 2 non-randomized, open label, uncontrolled, efficacy and safety study. Study participants will receive two priming doses of 0.5mL of DPX-Survivac 21 days apart and up to six 0.1ml maintenance injections every two months with low dose metronomic oral cyclophosphamide (50 mg BID) for one year or until disease progression, whichever occurs first. Pembrolizumab 200 mg will be administered every 3 weeks for up to one year or until disease progression, whichever occurs first.
This is a Phase 2, non-randomized, open-label, uncontrolled, efficacy and safety trial. Participants will receive 2 priming injections (0.5ml) of DPX-Survivac 3 weeks apart on Study Days 7 and 28. In addition, up to 6 maintenance injections (0.1ml) over the course of the study occurring on Study Days 84, 140, 196, 252, 308, and 364. All injections will be given under the skin of the upper thigh. Participants will receive metronomic oral cyclophosphamide (50mg BID; 7 days on / 7 days off) for study period. Pembrolizumab 200mg will be administered intravenously every 3 weeks, commencing on study day 7, to a total of 18 infusions. If a participant is removed from the trial prior to the completion of at least 4 doses of Pembrolizumab and 3 injections of DPX-Survivac, that particiapnt may be replaced to determine the efficacy of treatment in a minimum of 16 participants. DPX-Survivac injection sites will be evaluated throughout the study and if evidence of significant reaction, an Injection site reaction biopsy will be sought. During the course of the study, blood will be drawn to evaluate immune cells and the effect that DPX Survivac will have on the participants immune system. During all treatment cycles a physical exam and questions about the participants general health will be performed. Participants will undergo "re-staging" to assess the status of their disease at approximately study day 70 (if there is evidence of Grade 2 or greater injection site reaction or ulceration evident on study day 49) or routinely at approximately study day 91, and again at end of study or study withdrawal for all participants. A follow-up tumour biopsy will be requested between study day 77-83 for participants with any grade 2 or greater Injection site reaction or ulceration on SD49 or between SD98 and SD104 if no evidence of injection site reaction or ulceration. Upon completion of study, participants will be monitored every 2 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
DPX-Survivac Priming dose of 0.5ml on Study days 7 and 28. DPX-Survivac Booster dose of 0.1ml on Study days 84, 140, 196, 252, 308, and 364.
Pembrolizumab 200mg administered intravenously every 3 weeks, commencing on study day 7 to a total of 18 infusions
Cyclophosphamide 50mg twice daily by mouth, administered 7 days on / 7 days off, stating at study day 0, until study day 384
Tom Baker Cancer Centre - Alberta Health Services
Calgary, Alberta, Canada
Nova Scotia Health Authority: Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
To document the objective response rate using modified Cheson criteria to treatment with DPX-Survivac and low dose cyclophosphamide administered together with Pembrolizumab in participants with recurrent, survivin-expressing B cell lymphomas
Time frame: 1 Year
To document changes in tumour volume using waterfall analyses
Tumor volume measurements will be obtained at multiple time points by adding the volumes of the perpendicular measurements for up to 6 target lesions
Time frame: 1 Year
To document the toxicity profile
Number of participants with abnormal laboratory values and/or adverse events related to treatment will be assessed.
Time frame: 1 Year
To document duration of response using modified Cheson criteria.
Completing response assessment post radiology
Time frame: 2 Years
To document time to next treatment
time lapse between current and next treatment
Time frame: 2 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada