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NCT04920617PHASE2Recruiting

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

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Start Date

6/18/2021

Completion Date

4/1/2025

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

DPX-Survivac

DRUG

Pembrolizumab

DRUG

CPA

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Conditions

Relapsed Diffuse Large B-cell LymphomaRefractory Diffuse Large B-cell Lymphoma

Locations

Compassionate Cancer Care Medical Group

Fountain Valley, California 92708

United States

Boca Raton Regional Hospital

Boca Raton, Florida 33486

United States

BRCR Medical Center Inc.

Hollywood, Florida 33021

United States

BRCR Medical Center Inc.

Plantation, Florida 33322

United States

Comprehensive Hematology and Oncology

St. Petersburg, Florida 33709

United States

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia 30342

United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana 70112

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico 87505

United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina 27834

United States

Gabrail Cancer Center Research

Canton, Ohio 44718

United States

University of Toledo Medical Center

Toledo, Ohio 43614

United States

Toledo Clinic Cancer Center

Toledo, Ohio 43623

United States

Allegheny Health Network (AHN) West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Reading Hospital - McGlinn Cancer Institute

West Reading, Pennsylvania 19611

United States

Prairie Lakes Health Care System

Watertown, South Dakota 57201

United States

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Epworth Freemasons Hospital

Melbourne, Victoria 3002

Australia

Box Hill Hospital

Melbourne, Victoria 3128

Australia

Westmead Hospital

Westmead, 2145

Australia

Saskatoon Cancer Center

Saskatoon, Saskatchewan S7H 4H4

Canada

Hôpital Avicenne

Bobigny, 93000

France

Centre d'Oncologie de Gentilly

Nancy, 54000

France

Hôpital Privé du Confluent

Nantes, 44277

France

Centre Antoine Lacassagne

Nice, 06189

France

Hôpital Saint-Antoine

Paris, 75012

France

Hôpital de la Pitié-Salpêtrière

Paris, 75013

France

Hôpital Necker

Paris, 75015

France

CHU Bordeaux- Hôpital Haut Lévêque

Pessac, 33600

France

Centre Hospitalier de Périgueux

Périgueux, 24019

France

Centre Hospitalier de Saint-Quentin

Saint-Quentin, 02321

France

Debreceni Egyetem Klinikai Központ

Debrecen, 4032

Hungary

SzSzBM Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400

Hungary

North Shore Hospital

Auckland, Auckland Province 0622

New Zealand

Palmerston North Hospital

Palmerston North, Manawatu 4414

New Zealand

Szpitale Pomorskie Sp. z o. o.

Gdynia, 85-519

Poland

Wojewódzki Szpital Specjalistyczny w Legnicy

Legnica, 59-220

Poland

SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, 10-228

Poland

Centrum Medyczne Pratia Poznań

Skórzewo, 60-185

Poland

Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie

Warsaw, 02-781

Poland

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

Bucharest, 022328

Romania

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

Cluj-Napoca, 400015

Romania

University Clinical Center of Serbia

Belgrade, 11000

Serbia

Oncology Institute of Vojvodina

Kamenitz, 21204

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Clinical Hospital Center Zemun

Zemun, 11080

Serbia

Hospital Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Universitario de Burgos

Burgos, 09006

Spain

Hospital Universitario Virgen del Rocío

Seville, 41013

Spain