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