DPX-Survivac and Checkpoint Inhibitor in DLBCL

Phase 2

Completed

• Conditions: Adult Diffuse Large Cell Lymphoma; Recurrent; Adult Refractory Diffuse Large B-Cell Lymphoma
• Interventions: Biological: DPX-Survivac; Biological: Pembrolizumab; Drug: Cyclophosphamide 50mg

• Registration Number: NCT03349450
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Study Start: 2018-03-13
• Primary Completion: 2021-10-31
• Status Verified: 2023-07
• Study Completion: 2023-07-18
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm-Investigational	DPX-Survivac	DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally.
Single Arm-Investigational	Pembrolizumab	DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally.
Single Arm-Investigational	Cyclophosphamide 50mg	DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally.

Primary Outcome Measures

Name	Time	Method
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	1 Year

Secondary Outcome Measures

Name	Time	Method
To document changes in tumour volume using waterfall analyses	1 Year	Tumor volume measurements will be obtained at multiple time points by adding the volumes of the perpendicular measurements for up to 6 target lesions
To document the toxicity profile	1 Year	Number of participants with abnormal laboratory values and/or adverse events related to treatment will be assessed.
To document time to next treatment	2 Years	time lapse between current and next treatment
To document duration of response using modified Cheson criteria.	2 Years	Completing response assessment post radiology

Trial Locations

Locations (6)

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Tom Baker Cancer Centre - Alberta Health Services; 🇨🇦 Calgary, Alberta, Canada

Nova Scotia Health Authority: Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Sunnybrook Health Sciences Centre, Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada