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RECRUITING

NCT04920617

PHASE2

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

Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2021-06-18

Completion Date

2025-04

Last Updated

2023-04-07

Healthy Volunteers

Conditions

Relapsed Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma

Interventions

DRUG

DPX-Survivac

SC injection on D7 and D28, then every 8 weeks

DRUG

Pembrolizumab

IV infusion every 3 weeks

DRUG

CPA

50 mg twice daily, week on then week off

Key Inclusion Criteria: * 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) * Willing to provide pre-treatment and on-treatment tumor biopsy tissue. * Meet protocol-specified laboratory requirements * Life expectancy \> 3 months. Key Exclusion Criteria: * 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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)