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Cancer Vaccine

Pembrolizumab for Diffuse Large B-Cell Lymphoma (SPiReL Trial)

Phase 2
Waitlist Available
Led By Neil L Berinstein, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
D. for subjects with transformed lymphoma, a treatment for indolent lymphoma within the last 2 years
B. partial response or measureable disease after first line therapy (who are not candidates for ASCT) or after second or third line therapy without disease progression or,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

SPiReL Trial Summary

This trial is testing a new cancer treatment that consists of two priming doses of a 0.5 mL injection of DPX-Survivac, given 21 days apart, followed by up to six maintenance injections of 0.1 mL every two months for one year. The injections will be given with low-dose metronomic oral cyclophosphamide (50 mg twice daily) 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.

Eligible Conditions
  • Adult Refractory Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Recurrence

SPiReL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have received treatment for a slow-growing lymphoma in the past two years.
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You have shown a positive response to initial treatment, or if you have undergone multiple treatments without the disease getting worse.
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You have been diagnosed with DLBCL and it has come back even after trying different treatments.
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You have experienced a relapse and have received treatment at least 90 days after aggressive initial chemotherapy, stem cell transplantation, CAR-T therapy, or aggressive second-line combination therapy.
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You have had a relapse of cancer after receiving non-aggressive treatment with or without Rituximab.
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You are expected to live for at least 6 more months.

SPiReL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
To document changes in tumour volume using waterfall analyses
To document duration of response using modified Cheson criteria.
To document the toxicity profile
+1 more
Other outcome measures
Exploratory Outcome 1
Exploratory Outcome 2
Exploratory Outcome 3

SPiReL Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm-InvestigationalExperimental Treatment3 Interventions
DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Cyclophosphamide 50mg
2015
Completed Phase 2
~360
DPX-Survivac
2013
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
651 Previous Clinical Trials
1,542,664 Total Patients Enrolled
ImmunoVaccine Technologies, Inc. (IMV Inc.)Industry Sponsor
10 Previous Clinical Trials
557 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,675 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently looking for participants?

"As stated on clinicaltrials.gov, this medical trial is no longer actively seeking candidates as the last update was made November 9th 2022. Despite that there are still 3515 other trials open to patient recruitment at present. This particular study originally posted on March 13th of 2018."

Answered by AI

What is the current size of the cohort participating in this clinical trial?

"This study has ceased to accept participants for the time being. It was first posted on March 13th 2018, and its most recent edit occured November 9th 2022. Those seeking alternative clinical trials may find success with 1769 active studies involving recurrent illness or 1746 studies related to DPX-Survivac recruitment."

Answered by AI

Is there a precedent for investigating the effects of DPX-Survivac?

"Since its introduction in the late 1990s, DPX-Survivac has been subject to 1326 completed clinical trials. Currently, 1746 trials are actively recruiting patients; many of these studies centered around Halifax."

Answered by AI

What is the breadth of this trial's scope across various medical sites?

"This clinical trial is currently running at seven locations, including the Nova Scotia Health Authority: Queen Elizabeth II Health Sciences Centre in Halifax,Tom Baker Cancer Centre - Alberta Health Services in Calgary and Sunnybrook Health Sciences Centre, Odette Cancer Centre in Toronto. The remaining 4 sites are also included here."

Answered by AI

To what end is DPX-Survivac typically utilized?

"DPX-Survivac is frequently utilized to battle malignant melanoma of the skin. Furthermore, it may prove helpful in cases such as recurrent cervical cancer, leukemia and refractory or relapsed mediastinal large b-cell lymphoma."

Answered by AI

Has DPX-Survivac received regulatory approval from the FDA?

"Due to the lack of efficacy data, DPX-Survivac's safety rating is 2 based on Power's metric. This phase 2 trial has provided some evidence supporting its relative safety but not much in terms of effectiveness."

Answered by AI
~4 spots leftby Mar 2025