RecruitingPhase 2NCT04920617

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

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)

Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Enrollment

102 participants

Start Date

Jun 18, 2021

Study Type

INTERVENTIONAL

Conditions

Refractory Diffuse Large B-Cell Lymphoma Relapsed Diffuse Large B Cell Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a cancer vaccine (DPX-Survivac), an immunotherapy drug (pembrolizumab), and low doses of cyclophosphamide for people with diffuse large B-cell lymphoma (DLBCL, an aggressive blood cancer) that has returned or stopped responding to at least two prior treatments. **You may be eligible if:** - You are 18 or older and have confirmed DLBCL that has progressed after at least two prior treatment lines - Your prior treatment included both rituximab (or another CD20 drug) and an anthracycline chemotherapy - You are not a candidate for, or have already failed, stem cell transplant or CAR-T cell therapy - You have at least one measurable tumor - Your life expectancy is over 3 months - Your overall health is good (ECOG 0–1, or ECOG 2 with special approval) **You may NOT be eligible if:** - Your lymphoma has spread to the brain or spinal fluid - You had chemotherapy, immunotherapy, radiation, or major surgery within the past 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDPX-Survivac

SC injection on D7 and D28, then every 8 weeks

DRUGPembrolizumab

IV infusion every 3 weeks

DRUGCPA

50 mg twice daily, week on then week off

Locations(50)

Compassionate Cancer Care Medical Group

Fountain Valley, California, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

BRCR Medical Center Inc.

Hollywood, Florida, United States

BRCR Medical Center Inc.

Plantation, Florida, United States

Comprehensive Hematology and Oncology

St. Petersburg, Florida, United States

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

University of Toledo Medical Center

Toledo, Ohio, United States

Toledo Clinic Cancer Center

Toledo, Ohio, United States

Allegheny Health Network (AHN) West Penn Hospital

Pittsburgh, Pennsylvania, United States

Reading Hospital - McGlinn Cancer Institute

West Reading, Pennsylvania, United States

Prairie Lakes Health Care System

Watertown, South Dakota, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Epworth Freemasons Hospital

Melbourne, Victoria, Australia

Box Hill Hospital

Melbourne, Victoria, Australia

Westmead Hospital

Westmead, Australia

Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada

Hôpital Avicenne

Bobigny, France

Centre d'Oncologie de Gentilly

Nancy, France

Hôpital Privé du Confluent

Nantes, France

Centre Antoine Lacassagne

Nice, France

Hôpital Saint-Antoine

Paris, France

Hôpital de la Pitié-Salpêtrière

Paris, France

Hôpital Necker

Paris, France

CHU Bordeaux- Hôpital Haut Lévêque

Pessac, France

Centre Hospitalier de Périgueux

Périgueux, France

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary

SzSzBM Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, Hungary

North Shore Hospital

Auckland, Auckland Province, New Zealand

Palmerston North Hospital

Palmerston North, Manawatu, New Zealand

Szpitale Pomorskie Sp. z o. o.

Gdynia, Poland

Wojewódzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, Poland

Centrum Medyczne Pratia Poznań

Skórzewo, Poland

Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie

Warsaw, Poland

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

Bucharest, Romania

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

Cluj-Napoca, Romania

University Clinical Center of Serbia

Belgrade, Serbia

Oncology Institute of Vojvodina

Kamenitz, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Clinical Hospital Center Zemun

Zemun, Serbia

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT04920617

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