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Relapsed Diffuse Large B-cell LymphomaPhase 2VITALIZENCT04920617

DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 2 study testing DPX-Survivac, Pembrolizumab and CPA in people with Relapsed Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 50 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DPX-Survivac, Pembrolizumab and CPA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
50 sitesin 10 countries
Study dates
18 Jun 2021to Apr 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥ 18 years of age who are willing and able to provide written informed consent
  • Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.
  • 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.
  • Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).
  • Subjects must have failed or be ineligible for ASCT or CAR-T
  • Have at least one bi-dimensionally measurable lesion per Lugano (2014)
Show all 9Show fewer
  • Willing to provide pre-treatment and on-treatment tumor biopsy tissue.
  • Meet protocol-specified laboratory requirements
  • Life expectancy > 3 months.

Who cannot join

  • Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis
  • Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter
  • Radiotherapy within 14 days of day 0
  • Autologous stem cell transplant (ASCT) within ˂100 days prior to D0
  • Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0
  • Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years
  • Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)
  • Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment

Trial locations and contacts

50 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

50 sites in 10 countries

United States17 sites, 10 recruiting

  • Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342

    Stacey Brown, 404-780-7965, Stacey.brown@northside.com

    Melhem Solh, MD, 404-255-1930, msolh@bmtga.com

    Recruiting

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

    Withdrawn

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Withdrawn

  • Compassionate Cancer Care Medical Group

    Fountain Valley, California, 92708

    Eric Lee, MD, 714-698-0300, ericlee@compcancercare.com

    Haresh Jhangiani, MD, 714-698-0300, hjhangiani1@gmail.com

    Recruiting

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

    Denise Brigham, 252-744-4924, brighamd16@ecu.edu

    Darla Liles, MD

    Recruiting

  • BRCR Medical Center Inc.

    Hollywood, Florida, 33021

    Withdrawn

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Jill Weisenbach, 317-274-2848, jweisenb@iupui.edu

    Michael Robertson, MD

    Recruiting

  • Tulane Cancer Center Office of Clinical Research

    New Orleans, Louisiana, 70112

    Leta Ko, 504-988-6120, lko@tulane.edu

    Nakhle Saba, MD

    Recruiting

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Scott Degenhardt, 402-691-5257, sdegenhardt@NebraskaCancer.com

    Stefano Tarantolo, MD

    Recruiting

  • Allegheny Health Network (AHN) West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Diane Pershing, 412-578-5987, diane.radeshak@ahn.org

    Rich Wonder, 412-578-4492, Rich.Wonder@ahn.org

    Recruiting

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322

    Withdrawn

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

    Doreen Padilla, 505-913-8944, doreen.padilla@quantumsantafe.com

    Karen LoRusso, MD

    Recruiting

  • Comprehensive Hematology and Oncology

    St. Petersburg, Florida, 33709

    Withdrawn

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

    Withdrawn

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

    Pam Shoup, 419-214-4236, PShoup@toledoclinic.com

    Rex Mowat, MD

    Recruiting

  • Prairie Lakes Health Care System

    Watertown, South Dakota, 57201

    Withdrawn

  • Reading Hospital - McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611

    Barbara Miller, 484-628-8549, Barbara.miller@towerhealth.org

    Terrence Cescon, MD

    Recruiting

Other trials in United States

France10 sites, 10 recruiting

  • Hôpital Avicenne

    Bobigny, 93000

    Geoffrey Edouart, 01 48 95 75 05, geoffrey.edouart@aphp.fr

    Thorsten Braun, MD

    Recruiting

  • Centre d'Oncologie de Gentilly

    Nancy, 54000

    Thomas Lelu, 03 55 68 55 18, t.lelu@ilcgroupe.fr

    Serge Bologna, MD

    Recruiting

  • Hôpital Privé du Confluent

    Nantes, 44277

    Nathalie Hugon, 02 28 27 21 72, NATHALIE.HUGON@groupeconfluent.fr

    Sophie Sadot-Lebouvier, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Dalila Wakrim, 04 92 03 14 42, dalila.wakrim@nice.unicancer.fr

    Frédéric Peyrade, MD

    Recruiting

  • Hôpital Saint-Antoine

    Paris, 75012

    Anne Vekhoff, MD, 01 49 28 34 29, anne.vekhoff@aphp.fr

    Mohamad Mohty, PU-PH

    Recruiting

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013

    Raouf Benchikh, 01 84 82 70 31, raouf.benchikh@aphp.fr

    Sylvain Choquet, MD

    Recruiting

  • Hôpital Necker

    Paris, 75015

    Yohan Demay, 01 44 49 46 57, yohan.demay@aphp.fr

    Adélaïde Duperray, 01 44 49 52 03, adelaide.duperray@aphp.fr

    Recruiting

  • Centre Hospitalier de Périgueux

    Périgueux, 24019

    Aude Jouinot, 05 53 45 29 73, aude.jouinot@ch-perigueux.fr

    Claire Calmettes, MD

    Recruiting

  • CHU Bordeaux- Hôpital Haut Lévêque

    Pessac, 33600

    Souheyla Bouteman, 05 57 65 60 18, souheyla.boutemane@chu-bordeaux.fr

    Nathalie Franzl, 05 57 62 33 23, nathalie.franzl@chu-bordeaux.fr

    Recruiting

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321

    Abdelkrim Boulanouar, 03 23 06 78 61, a.boulanouar@ch-stquentin.fr

    Réda Garidi, MD

    Recruiting

Other trials in France

Poland5 sites, 5 recruiting

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 85-519

    Karolina Cicha, +48 58 726 0380, info.onkocwbk@szpitalepomorskie.eu

    Wanda Knopińska-Posłuszny, MD

    Recruiting

  • Wojewódzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220

    Jadwiga Holodja, MD, 505-149-579, jadwiga.holojda@szpital.legnica.pl

    Barbara Boruta-Pankowska, 668-446-646, barbara.pankowska@szpital.legnica.pl

    Recruiting

  • SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

    Jakub Zawadzki, +48 89-539-87-56, jakub.zawadzki@poliklinika.net

    Marta Witowska, +48 89-539-87-56, marta.lapiejko@poliklinika.net

    Recruiting

  • Centrum Medyczne Pratia Poznań

    Skórzewo, 60-185

    Natalia Szymalak, 512-491-461, natalia.bigott@pratia.com

    Lukasz Pruchniewski, MD

    Recruiting

  • Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie

    Warsaw, 02-781

    Anna Pich, + 48 22 546 2223, anna.pich@pib-nio.pl

    Jan Walewski, MD

    Recruiting

Other trials in Poland

Australia4 sites, 4 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Christine Hoare, +61 481 910 999, christine.hoare@sa.gov.au

    Pratyush Giri, MD

    Recruiting

  • Epworth Freemasons Hospital

    Melbourne, Victoria, 3002

    Connie Barlas, MD, +61 3 9516 2374, Connie.barlas@epworth.org.au

    Costas Yannakou, MD

    Recruiting

  • Box Hill Hospital

    Melbourne, Victoria, 3128

    Liz Arnold, +61 3 9094 9516, liz.arnold@monash.edu

    Denise Lee, MD

    Recruiting

  • Westmead Hospital

    Westmead, 2145

    Angela Bayley, +61 2 8890 7219, Angela.bayley@sydney.edu.au

    Amanda Johnston, MD

    Recruiting

Other trials in Australia

Serbia4 sites, 4 recruiting

  • University Clinical Center of Serbia

    Belgrade, 11000

    Darko Antic, MD, +381 63 634 747, darko.antic1510976@gmail.com

    Nikica Sabljic, +381 61 192 46 68, nsabljic19@gmail.com

    Recruiting

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

    Dijana Zekic, +381 64 08 00 868, klinicka.istrazivanja@onk.ns.ac.rs

    Lazar Popovic, MD

    Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Ana Dragovic, +381 65 325 97 65, anadragovicana@gmail.com

    Predrag Djurdjevic, MD

    Recruiting

  • Clinical Hospital Center Zemun

    Zemun, 11080

    Tamara Bibic, +381 60 511 10 45, tmedic83@gmail.com

    Zorica Cvetkovic, MD

    Recruiting

Other trials in Serbia

Spain3 sites, 3 recruiting

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

    Nuria Pérez, +34 93 291 90 00 ext. 8538, nperezg@santpau.cat

    Javier Briones, MD

    Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006

    Raquel Alcaraz, +34 947281800 ext. 36078, ralcaraz@hubu.es

    Jorge Labrado Gómez, MD

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Rocío Jiménez, +34 95 501 32 77, rociojimenezalvarez@gmail.com

    Fatima de la Cruz Vicente, MD

    Recruiting

Other trials in Spain

Hungary2 sites, 2 recruiting

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

    Gabriella Mezei, MD, +36 30 657 5238, gmezei@gmail.com

    Árpád ILLÉS, MD

    Recruiting

  • SzSzBM Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

    Zsolt HORVÁTH, +36 20 998 5123, horvathzsolt00@gmail.com

    László REJTŐ, MD

    Recruiting

Other trials in Hungary

New Zealand2 sites, 2 recruiting

  • North Shore Hospital

    Auckland, Auckland Province, 0622

    Sophie Leitch, MD, 64 9 486 8900, Sophie.Leitch@waitematadhb.govt.nz

    Sophie Leitch, MD

    Recruiting

  • Palmerston North Hospital

    Palmerston North, Manawatu, 4414

    RCTS Clinical Trials Unit, +64 6 350 8254, jacqui.toms@midcentraldhb.govt.nz

    Dixon Grant, MD

    Recruiting

Other trials in New Zealand

Romania2 sites, 2 recruiting

  • Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"

    Bucharest, 022328

    Monica Rosoiu, MD, +4078 3163 970, mirela.rosoiu@arensia-em.com

    Laura-Aifer Calustian, MD

    Recruiting

  • The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.

    Cluj-Napoca, 400015

    Nataliia Moskalenko, +4073 5888 501, nataliia.moskalenko@arensia-em.com

    Hanna Varytska, +4076 0818 421, hanna.varytska@arensia-em.com

    Recruiting

Other trials in Romania

Canada1 site, 1 recruiting

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan, S7H 4H4

    Jonathan Glum, 306-655-1896, jonathan.glum@saskcancer.ca

    Mark Bosch, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

Read the detailed description

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

The study will enroll up to 102 subjects. Eligible subjects will be randomized (1:1) to receive:

  • Arm 1: DPX-Survivac, pembrolizumab and intermittent, low-dose CPA; or,
  • Arm 2: DPX-Survivac and pembrolizumab

All subjects will receive two 0.5 mL doses of DPX-Survivac 3 weeks apart on day 7 (D7) and D28 followed by up to twelve 0.1 mL doses of DPX-Survivac, 8 weeks apart (Q8W).

All subjects will receive pembrolizumab intravenously (IV) at a flat dose of 200 mg starting at D7 and on day 1 of each 3-week cycle thereafter (i.e., D28, D49, D70 etc.) (Q3W).

For subjects randomized to Arm 1, intermittent oral CPA at a dose of 50 mg twice a day (BID) is administered from D0 to D6 (7 days) followed by 7 days off. This 14-day cycle of "7 days on and 7 days off" will be repeated until the end of study treatment.

Being tested
DPX-Survivac, Pembrolizumab, CPA
Keywords
Immunotherapy, T cell activation, DLBCL, Anti-PD-1, CAR-T ineligible, ASCT ineligible
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPX-SurvivacDrug

    Also called maveropepimut-S

    SC injection on D7 and D28, then every 8 weeks

  • PembrolizumabDrug

    Also called MK-3475, Keytruda

    IV infusion every 3 weeks

  • CPADrug

    Also called Intermittent, low-dose cyclophosphamide, Procytox, Cytoxan

    50 mg twice daily, week on then week off

Study groups in NCT04920617
Study groupRoleWhat they receive
Arm 1: DPX-Survivac, pembrolizumab, CPAExperimentalSubjects 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.
Receives: Drug: DPX-Survivac; Drug: Pembrolizumab; Drug: CPA
Arm 2: DPX-Survivac, pembrolizumabExperimentalSubjects 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.
Receives: Drug: DPX-Survivac; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) in each of the study arms

    Centrally evaluated using Lugano (2014)

    Measured: Approximately 24 months

Secondary outcomes (8)

  1. Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms

    Measured: Approximately 24 months

  2. Duration of response (DOR) in each of the study arms

    Centrally evaluated using Lugano (2014)

    Measured: Approximately 24 months

  3. Time to response in each of the study arms

    Centrally evaluated using Lugano (2014)

    Measured: Approximately 24 months

  4. Progression-Free Survival in each of the study arms

    Centrally evaluated using Lugano (2014)

    Measured: Approximately 48 months

  5. Disease control rate (DCR) in each of the study arms

    Centrally evaluated using Lugano (2014)

    Measured: Approximately 24 months

  6. Complete response (CR) rate in each of the study arms

    Centrally evaluated using Lugano (2014)

    Measured: Approximately 24 months

  7. Changes in Patient Reported Outcomes using the FACT-Lym Assessment

    The FACT-Lym is a validated questionnaire that consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale).

    Measured: Approximately 24 months

  8. Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment

    The EQ-5D-5L is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression.

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start18 Jun 2021
  3. Primary completionOct 2024 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920617
Sponsor's protocol ID
P1605-SUR-D23
Other IDs
KEYNOTE-C54
Acronym
VITALIZE
Status last verified
Aug 2022
First submitted
28 May 2021
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DPX-Survivac, Pembrolizumab and CPA in people with Relapsed Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 50 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, France, Poland, Australia, Serbia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) in each of the study arms (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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