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Cancer Vaccine

DPX-Survivac + Pembrolizumab for Lymphoma (VITALIZE Trial)

Phase 2
Recruiting
Research Sponsored by ImmunoVaccine Technologies, Inc. (IMV Inc.)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have failed or be ineligible for ASCT or CAR-T
Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 48 months
Awards & highlights

VITALIZE Trial Summary

This trial is testing a new cancer treatment combining two drugs, one of which is a new experimental drug. They are testing to see if it is safe and effective in people with a certain type of lymphoma that has come back or didn't respond to other treatments.

Who is the study for?
Adults over 18 with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) who've had at least two prior treatments, including an anthracycline and rituximab. They must have a measurable lesion, life expectancy over 3 months, decent performance status, and be ineligible for or failed ASCT or CAR-T therapy. Excludes those with recent transplants, active autoimmune diseases requiring treatment within the past 2 years, recent radiotherapy or other therapies before the trial start.Check my eligibility
What is being tested?
This Phase 2b study is testing DPX-Survivac and pembrolizumab's safety and effectiveness in treating DLBCL when given alone or combined with low-dose cyclophosphamide (CPA). Participants are randomly assigned to receive these interventions to see how well they work against this type of lymphoma.See study design
What are the potential side effects?
Possible side effects include immune system reactions that can cause inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment-induced exhaustion, potential blood disorders due to bone marrow suppression by chemotherapy agents like CPA.

VITALIZE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot have stem cell or CAR-T therapy due to ineligibility or past treatment failure.
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I have been diagnosed with a specific type of lymphoma according to WHO 2016.

VITALIZE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) in each of the study arms
Secondary outcome measures
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment
Changes in Patient Reported Outcomes using the FACT-Lym Assessment
Complete response (CR) rate in each of the study arms
+5 more
Other outcome measures
Cell mediated immune response
Changes in immune cell infiltration in tumor biopsies
Objective Response Rate (ORR) based on PD-L1 expression
+3 more

VITALIZE Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: DPX-Survivac, pembrolizumabExperimental Treatment2 Interventions
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. Subjects randomized to Arm 2 will not receive CPA.
Group II: Arm 1: DPX-Survivac, pembrolizumab, CPAExperimental Treatment3 Interventions
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. CPA will be self-administered 50 mg BID for 7 days on and 7 days off starting on D0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DPX-Survivac
2013
Completed Phase 2
~90
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

ImmunoVaccine Technologies, Inc. (IMV Inc.)Lead Sponsor
10 Previous Clinical Trials
480 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,569 Total Patients Enrolled

Media Library

DPX-Survivac (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04920617 — Phase 2
B-Cell Lymphoma Research Study Groups: Arm 1: DPX-Survivac, pembrolizumab, CPA, Arm 2: DPX-Survivac, pembrolizumab
B-Cell Lymphoma Clinical Trial 2023: DPX-Survivac Highlights & Side Effects. Trial Name: NCT04920617 — Phase 2
DPX-Survivac (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04920617 — Phase 2

Frequently Asked Questions

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

Have there been any other investigations into the efficacy of DPX-Survivac?

"In 1997, City of Hope Comprehensive Cancer Center first initiated research on DPX-Survivac. Since then, a total of 1326 clinical trials have been completed and 1746 are ongoing across multiple sites; particularly in Greenville, North carolina."

Answered by AI

Is enrollment to this trial still available for participants?

"According to clinicaltrials.gov, this experiment is actively enrolling participants who meet the criteria. It was first listed on June 18th 2021 and has been revised as recently as November 21st 2022."

Answered by AI

What maladies does DPX-Survivac typically target?

"DPX-Survivac is commonly prescribed to patients suffering from malignant melanoma of the skin, as well as recurrent cervical cancer, leukemia, and refractory/relapsed mediastinal large B-cell lymphoma."

Answered by AI

In what numerous locations is this clinical research being conducted?

"The Brody School of Medicine at East Carolina University in Greenville, Oncology Hematology West, PC dba Nebraska Cancer Specialists in Omaha, and Saskatoon Cancer Center in Saskatoon are among the 15 sites offering this trial. There are also 12 additional centres hosting it."

Answered by AI

What adverse effects might arise from DPX-Survivac treatment?

"Although there is evidence of DPX-Survivac's safety, no clinical data exists that confirms its efficacy. Therefore, it has been assigned a score of 2 on our team at Power's scale from 1 to 3."

Answered by AI

How many participants are currently being monitored in this experiment?

"This clinical trial necessitates the participation of 102 qualified patients from multiple sites, such as Brody School of Medicine and Oncology Hematology West. Before joining in on this medical study, participants must meet all pre-defined inclusion requirements."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
2021. "DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04920617.
~13 spots leftby Oct 2024
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