A Phase 2 interventional study of DPX-Survivac and Pembrolizumab in Adult Diffuse Large Cell Lymphoma, Recurrent and Adult Refractory Diffuse Large B-Cell Lymphoma, sponsored by Sunnybrook Health Sciences Centre. Completed at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Treatment
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.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's enrollment of 25 is below the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible for participation in this trial, the subject must:
Has:
A. proven DLBCL with recurrence after first, second or tertiary treatment regimens for DLBCL or,
B. evidence of transformed lymphoma with past history of indolent lymphoma with current showing DLBCL) or,
C. double hit or high grade lymphomas, including Burkitts lymphoma and High Grade B-Cell lymphoma unclassifiable (with features intermediate between Burkitts and diffuse large B cell lymphoma)
Has had:
A. recurrence requiring therapy at least 90 days post aggressive combination chemotherapy (e.g. RCHOP, Hyper-CVAD or other aggressive "curative" combination), stem cell transplantation (ASCT), CART therapy, or aggressive second line combination therapy or,
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,
C. recurrence any time after non-aggressive combination or single agent therapy with or without Rituximab (i.e. CVP, CHL or, VP16) for first, second or third line disease or,
D. for subjects with transformed lymphoma, a treatment for indolent lymphoma within the last 2 years
Exclusion Criteria
The subject must be excluded from participating in the trial if the subject:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DPX-Survivac Priming dose of 0.5ml. DPX-Survivac Booster dose of 0.1ml. Pembrolizumab 200mg Intravenously. Cyclophosphamide 50mg Twice daily orally.
Biological: DPX-Survivac · Biological: Pembrolizumab · Drug: Cyclophosphamide 50mg
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
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
Objective Response Rate is the combined Complete Response (CR) and Partial Response (PR) rates using Cheson Criteria (2007) for evaluation. Site Qualified Investigators use radiological reports to calculate the decrease in tumour size from baseline at protocol specified time points.
Time frame: 1 Year
Duration of Response Using Modified Cheson Criteria.
Completing response assessment post radiology using the Cheson criteria
Time frame: 2 Years
Time to Next Treatment
time lapse between current and next treatment
Time frame: 42 months
Evidence of Regression Using Waterfall Analyses
Waterfall analysis is describing visually the participants best clinical response using the Modified Cheson Criteria (2007) and irRC (immune related response criteria). This includes Complete (CR), Partial (PR), Stable disease (SD) and Progressive Disease (PD). Participants are then categorized by their PD-L1 bio-marker response to show their tumour size decrease (in %) from baseline to their best response. Overall Response Rate (ORR) = CR+PR. Disease Control Rate (DCR) = CR+PR+SD.
Time frame: 1 year
Toxicity Profile
Safety will be assessed through patient reported and investigator observed Adverse Events (AE's) and graded using CTCAE version 4.03. This will also include physical examination and clinical laboratory tests. Specific attention will be placed upon injection site reactions and potential immune mediated AE's. Reporting will be on all AE's, regardless of relatedness, causality or severity and will include and AE's recorded from the time of participant consent to 30 days after treatment completion, resolution or lost-to-follow-up. Injection site reactions will be documented as grades of erythema, induration, pain, edema, ulceration or other. See Adverse Event section below for details.
Time frame: 1 year
Changes in Circulating T Cell Immune Responses to Survivin and Relationship to Peripheral B Cell Numbers
Therapy with DPX-Survivac is expected to increase the frequency and activity of survivin-specific anti-tumour T cells. Survivin-peptide specific T cell immune response will be measured by methods such as ELISpot assay to enumerate T cells that produce molecules associated with anti-tumour immune responses such as IFN-γ and/or Granzyme-B. Additional immunological assays such as MHC-peptide multimer staining for survivin-specific CD8+ T cells, or multi-parametric flow cytometry for antigen-activated T cells and their phenotypes may also be performed for select subjects. Other exploratory immunologic assessments may be performed on frozen PBMC samples and subject plasma/serum if a novel method becomes available during the course of the study.
Time frame: 1 year
Changes in T Cell and T Cell Subset Infiltration and Gene Expression Pathways in Treatment Compared to Pre-treatment Tumour Biopsies
Therapy with DPX-Survivac is expected to increase the frequency and activity of survivin-specific anti-tumour T cells. Survivin-peptide specific T cell immune response will be measured by methods such as ELISpot assay to enumerate T cells that produce molecules associated with anti-tumour immune responses such as IFN-γ and/or Granzyme-B. Additional immunological assays such as MHC-peptide multimer staining for survivin-specific CD8+ T cells, or multi-parametric flow cytometry for antigen-activated T cells and their phenotypes may also be performed for select subjects. Other exploratory immunologic assessments may be performed on frozen PBMC samples and subject plasma/serum if a novel method becomes available during the course of the study.
Time frame: 1 year
Assess Potential Biomarkers of Immune and Clinical Response From Subject Clinical, Biological and Immunologic Data From Pre-treatment and On-treatment Tumour Biopsies
Tumour-specific T cells must migrate to the tumour site to mediate anti-tumour activity. We will quantitate changes in T cell infiltration and the expression profile of this T cells in tumour sites before and during treatment.
Time frame: 1 year
Relevant Biologic Assays That May be Identified During the Conduct of the Trial That May Have Immune or Clinical Relevance on Samples Already Collected
This will be determined at a later date
Time frame: 1 year
| Milestone | Single Arm-Investigational |
|---|---|
| Started | 25 |
| Completed | 5 |
| Not completed | 20 |
| Withdrew: Progressive disease | 19 |
| Withdrew: Adverse event | 1 |
Objective Response Rate is the combined Complete Response (CR) and Partial Response (PR) rates using Cheson Criteria (2007) for evaluation. Site Qualified Investigators use radiological reports to calculate the decrease in tumour size from baseline at protocol specified time points.
| Participants | Best Overall Response |
|---|---|
| Complete Response | 3 |
| Partial Response | 4 |
| Stable Disease | 6 |
| Progressive Disease | 12 |
Completing response assessment post radiology using the Cheson criteria
| months | Duration of Response |
|---|---|
| Duration of Response Using Modified Cheson Criteria. | 8.05 (7.07 to NA) |
time lapse between current and next treatment
| days | Intent-to-treat |
|---|---|
| Time to Next Treatment | 135.5 (37 to 909) |
Waterfall analysis is describing visually the participants best clinical response using the Modified Cheson Criteria (2007) and irRC (immune related response criteria). This includes Complete (CR), Partial (PR), Stable disease (SD) and Progressive Disease (PD). Participants are then categorized by their PD-L1 bio-marker response to show their tumour size decrease (in %) from baseline to their best response. Overall Response Rate (ORR) = CR+PR. Disease Control Rate (DCR) = CR+PR+SD.
| Participants | Best Overall Response in ITT | Best Overall Response in PD-L1+ |
|---|---|---|
| Participants with Progressive Disease | 12 | 3 |
| Overall Response Rate (participants with a Complete or Partial Response) | 7 | 6 |
| Disease Control Rate: Participants with CR+PR+ stable disease | 13 | 10 |
Safety will be assessed through patient reported and investigator observed Adverse Events (AE's) and graded using CTCAE version 4.03. This will also include physical examination and clinical laboratory tests. Specific attention will be placed upon injection site reactions and potential immune mediated AE's. Reporting will be on all AE's, regardless of relatedness, causality or severity and will include and AE's recorded from the time of participant consent to 30 days after treatment completion, resolution or lost-to-follow-up. Injection site reactions will be documented as grades of erythema, induration, pain, edema, ulceration or other. See Adverse Event section below for details.
| Participants | Single Arm-Investigational |
|---|---|
| Toxicity Profile | 25 |
Therapy with DPX-Survivac is expected to increase the frequency and activity of survivin-specific anti-tumour T cells. Survivin-peptide specific T cell immune response will be measured by methods such as ELISpot assay to enumerate T cells that produce molecules associated with anti-tumour immune responses such as IFN-γ and/or Granzyme-B. Additional immunological assays such as MHC-peptide multimer staining for survivin-specific CD8+ T cells, or multi-parametric flow cytometry for antigen-activated T cells and their phenotypes may also be performed for select subjects. Other exploratory immunologic assessments may be performed on frozen PBMC samples and subject plasma/serum if a novel method becomes available during the course of the study.
Results for this outcome have not been posted.
Therapy with DPX-Survivac is expected to increase the frequency and activity of survivin-specific anti-tumour T cells. Survivin-peptide specific T cell immune response will be measured by methods such as ELISpot assay to enumerate T cells that produce molecules associated with anti-tumour immune responses such as IFN-γ and/or Granzyme-B. Additional immunological assays such as MHC-peptide multimer staining for survivin-specific CD8+ T cells, or multi-parametric flow cytometry for antigen-activated T cells and their phenotypes may also be performed for select subjects. Other exploratory immunologic assessments may be performed on frozen PBMC samples and subject plasma/serum if a novel method becomes available during the course of the study.
Results for this outcome have not been posted.
Tumour-specific T cells must migrate to the tumour site to mediate anti-tumour activity. We will quantitate changes in T cell infiltration and the expression profile of this T cells in tumour sites before and during treatment.
Results for this outcome have not been posted.
This will be determined at a later date
Results for this outcome have not been posted.
Collected over Adverse Events were recorded for up to 14 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intent to Treat | 16/25 (64%) | 15/25 (60%) | 25/25 (100%) |
| Event | Intent to Treat |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 14/25 |
| PancreatitisHepatobiliary disorders | 1/25 |
| Event | Intent to Treat |
|---|---|
| Injection Site ReactionSkin and subcutaneous tissue disorders | 14/25 |
| NauseaGastrointestinal disorders | 10/25 |
| FatigueGeneral disorders | 9/25 |
| DiarrheaGastrointestinal disorders | 6/25 |
| Rash Maculo-papularSkin and subcutaneous tissue disorders | 5/25 |
| Abdominal PainGastrointestinal disorders | 3/25 |
| AnemiaBlood and lymphatic system disorders | 3/25 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/25 |
| HeadacheNervous system disorders | 3/25 |
| Neutrophil Count DecreasedBlood and lymphatic system disorders | 3/25 |
| Age, Continuous(years) | Single Arm-Investigational |
|---|---|
| Median | 74 (50 to 82) |
| Age, Customized(Participants) | Single Arm-Investigational |
|---|---|
| > 70 years | 20 |
| < 70 years | 5 |
| Sex: Female, Male(Participants) | Single Arm-Investigational |
|---|---|
| Female | 14 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | Single Arm-Investigational |
|---|---|
| White | 16 |
| Asian | 9 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Single Arm-Investigational |
|---|---|
| Grade 0 - Normal activity. Fully active. Carry on all pre-disease performance, no restriction. | 11 |
| Grade 1 - Symptoms, but ambulatory. Restricted in physically strenuous activity. | 14 |
| Cell of Origin(Participants) | Single Arm-Investigational |
|---|---|
| GCB | 14 |
| Non-GCB | 11 |
| Ann Arbor Stage at Screening(Participants) | Single Arm-Investigational |
|---|---|
| I: 1 lymph node region or lymph organ II: 2+ lymph node regions on same side of diaphragm | 14 |
| III: Lymph node regions on both sides of diaphragm IV: Widespread/ diffuse in extralymphatic organs | 11 |
| International Prognostic Index (IPI) at Screening(Participants) | Single Arm-Investigational |
|---|---|
| 0-2 (low - low/intermediate) | 14 |
| 3-5 (intermediate/high - high) | 11 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — For original data, contact SPiReL@sunnybrook.ca. Individual patient data will be de-identified, however, data can be shared for a period of up to 5 years after trial closure with formal Confidentiality and Data Transfer agreements in place as appropriate. A data dictionary will not be shared, the Statistical Analysis Plan can be made available with publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Up to 5 years after the closure of the trial
Access criteria: contact SPiReL@sunnybrook.ca
Ran from Mar 2018 to primary completion in Oct 2021, 43 months.
Results were first posted in May 2026, 4 years 6 months after primary completion.
Of 210 non-industry phase 2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 96. This study's 43 months is below that.
Counting every sponsor, half of 264 studies reached it within 52 months; a quarter within 35 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Maveropepimut-S
Lymphoma, Large B-Cell, Diffuse →
Sunnybrook Health Sciences Centre →