DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT ID: NCT04920617
Last Updated: 2023-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
102 participants
INTERVENTIONAL
2021-06-18
2025-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT06810778
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
NCT03038672
Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma
NCT03704714
Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
NCT01040871
Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
NCT03630159
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: DPX-Survivac, pembrolizumab, CPA
Subjects 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.
DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Pembrolizumab
IV infusion every 3 weeks
CPA
50 mg twice daily, week on then week off
Arm 2: DPX-Survivac, pembrolizumab
Subjects 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.
DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Pembrolizumab
IV infusion every 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Pembrolizumab
IV infusion every 3 weeks
CPA
50 mg twice daily, week on then week off
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
ImmunoVaccine Technologies, Inc. (IMV Inc.)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KEYNOTE-C54
Identifier Type: OTHER
Identifier Source: secondary_id
P1605-SUR-D23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.