Back to resultsDPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)
Primary Purpose
Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DPX-Survivac
Pembrolizumab
CPA
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed Diffuse Large B-cell Lymphoma focused on measuring Immunotherapy, T cell activation, DLBCL, Anti-PD-1, CAR-T ineligible, ASCT ineligible
Eligibility Criteria
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
Sites / Locations
- Compassionate Cancer Care Medical GroupRecruiting
- Boca Raton Regional Hospital
- BRCR Medical Center Inc.
- BRCR Medical Center Inc.
- Comprehensive Hematology and Oncology
- Blood and Marrow Transplant Group of GeorgiaRecruiting
- Indiana University Health Melvin and Bren Simon Cancer CenterRecruiting
- Tulane Cancer Center Office of Clinical ResearchRecruiting
- Oncology Hematology West, PC dba Nebraska Cancer SpecialistsRecruiting
- Christus St. Vincent Regional Cancer CenterRecruiting
- Brody School of Medicine at East Carolina UniversityRecruiting
- Gabrail Cancer Center Research
- University of Toledo Medical Center
- Toledo Clinic Cancer CenterRecruiting
- Allegheny Health Network (AHN) West Penn HospitalRecruiting
- Reading Hospital - McGlinn Cancer InstituteRecruiting
- Prairie Lakes Health Care System
- Royal Adelaide HospitalRecruiting
- Epworth Freemasons HospitalRecruiting
- Box Hill HospitalRecruiting
- Westmead HospitalRecruiting
- Saskatoon Cancer CenterRecruiting
- Hôpital AvicenneRecruiting
- Centre d'Oncologie de GentillyRecruiting
- Hôpital Privé du ConfluentRecruiting
- Centre Antoine LacassagneRecruiting
- Hôpital Saint-AntoineRecruiting
- Hôpital de la Pitié-SalpêtrièreRecruiting
- Hôpital NeckerRecruiting
- CHU Bordeaux- Hôpital Haut LévêqueRecruiting
- Centre Hospitalier de PérigueuxRecruiting
- Centre Hospitalier de Saint-QuentinRecruiting
- Debreceni Egyetem Klinikai KözpontRecruiting
- SzSzBM Korhazak es Egyetemi OktatokorhazRecruiting
- North Shore HospitalRecruiting
- Palmerston North HospitalRecruiting
- Szpitale Pomorskie Sp. z o. o.Recruiting
- Wojewódzki Szpital Specjalistyczny w LegnicyRecruiting
- SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w OlsztynieRecruiting
- Centrum Medyczne Pratia PoznańRecruiting
- Narodowy Instytut Onkologii im. Marii, Skłodowskiej-CurieRecruiting
- Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"Recruiting
- The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.Recruiting
- University Clinical Center of SerbiaRecruiting
- University Clinical Center KragujevacRecruiting
- Oncology Institute of VojvodinaRecruiting
- Clinical Hospital Center ZemunRecruiting
- Hospital Santa Creu i Sant PauRecruiting
- Hospital Universitario de BurgosRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1: DPX-Survivac, pembrolizumab, CPA
Arm 2: DPX-Survivac, pembrolizumab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Objective response rate (ORR) in each of the study arms
Centrally evaluated using Lugano (2014)
Secondary Outcome Measures
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms
Duration of response (DOR) in each of the study arms
Centrally evaluated using Lugano (2014)
Time to response in each of the study arms
Centrally evaluated using Lugano (2014)
Progression-Free Survival in each of the study arms
Centrally evaluated using Lugano (2014)
Disease control rate (DCR) in each of the study arms
Centrally evaluated using Lugano (2014)
Complete response (CR) rate in each of the study arms
Centrally evaluated using Lugano (2014)
Changes in Patient Reported Outcomes using the FACT-Lym Assessment
The FACT-Lym is a validated questionnaire that consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale).
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment
The EQ-5D-5L is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression.
Full Information
NCT ID
NCT04920617
First Posted
May 28, 2021
Last Updated
April 5, 2023
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04920617
Brief Title
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Acronym
VITALIZE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
Keywords
Immunotherapy, T cell activation, DLBCL, Anti-PD-1, CAR-T ineligible, ASCT ineligible
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: DPX-Survivac, pembrolizumab, CPA
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2: DPX-Survivac, pembrolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DPX-Survivac
Other Intervention Name(s)
maveropepimut-S
Intervention Description
SC injection on D7 and D28, then every 8 weeks
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda
Intervention Description
IV infusion every 3 weeks
Intervention Type
Drug
Intervention Name(s)
CPA
Other Intervention Name(s)
Intermittent, low-dose cyclophosphamide, Procytox, Cytoxan
Intervention Description
50 mg twice daily, week on then week off
Primary Outcome Measure Information:
Title
Objective response rate (ORR) in each of the study arms
Description
Centrally evaluated using Lugano (2014)
Time Frame
Approximately 24 months
Secondary Outcome Measure Information:
Title
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms
Time Frame
Approximately 24 months
Title
Duration of response (DOR) in each of the study arms
Description
Centrally evaluated using Lugano (2014)
Time Frame
Approximately 24 months
Title
Time to response in each of the study arms
Description
Centrally evaluated using Lugano (2014)
Time Frame
Approximately 24 months
Title
Progression-Free Survival in each of the study arms
Description
Centrally evaluated using Lugano (2014)
Time Frame
Approximately 48 months
Title
Disease control rate (DCR) in each of the study arms
Description
Centrally evaluated using Lugano (2014)
Time Frame
Approximately 24 months
Title
Complete response (CR) rate in each of the study arms
Description
Centrally evaluated using Lugano (2014)
Time Frame
Approximately 24 months
Title
Changes in Patient Reported Outcomes using the FACT-Lym Assessment
Description
The FACT-Lym is a validated questionnaire that consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale).
Time Frame
Approximately 24 months
Title
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment
Description
The EQ-5D-5L is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
Approximately 24 months
Other Pre-specified Outcome Measures:
Title
Objective Response Rate (ORR) based on PD-L1 expression
Description
Centrally evaluated using Lugano (2014) and central assessment of PD-L1 using validated 22C3 assay
Time Frame
Approximately 24 months
Title
Time to next treatment (TTNT) in each of the study arms
Time Frame
Approximately 48 months
Title
Overall survival (OS) in each of the study arms
Time Frame
Approximately 48 months
Title
Time to second objective disease progression (PFS2) in each of the study arms
Time Frame
Approximately 48 months
Title
Cell mediated immune response
Time Frame
Approximately 24 months
Title
Changes in immune cell infiltration in tumor biopsies
Time Frame
Approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Compassionate Cancer Care Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lee, MD
Phone
714-698-0300
Email
ericlee@compcancercare.com
First Name & Middle Initial & Last Name & Degree
Haresh Jhangiani, MD
Phone
714-698-0300
Email
hjhangiani1@gmail.com
First Name & Middle Initial & Last Name & Degree
Eric Lee, MD
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Withdrawn
Facility Name
BRCR Medical Center Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Withdrawn
Facility Name
BRCR Medical Center Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Withdrawn
Facility Name
Comprehensive Hematology and Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Withdrawn
Facility Name
Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Brown
Phone
404-780-7965
Email
Stacey.brown@northside.com
First Name & Middle Initial & Last Name & Degree
Melhem Solh, MD
Phone
404-255-1930
Email
msolh@bmtga.com
First Name & Middle Initial & Last Name & Degree
Melhem Solh, MD
Facility Name
Indiana University Health Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Weisenbach
Phone
317-274-2848
Email
jweisenb@iupui.edu
First Name & Middle Initial & Last Name & Degree
Michael Robertson, MD
Facility Name
Tulane Cancer Center Office of Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leta Ko
Phone
504-988-6120
Email
lko@tulane.edu
First Name & Middle Initial & Last Name & Degree
Nakhle Saba, MD
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Degenhardt
Phone
402-691-5257
Email
sdegenhardt@NebraskaCancer.com
First Name & Middle Initial & Last Name & Degree
Stefano Tarantolo, MD
Facility Name
Christus St. Vincent Regional Cancer Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doreen Padilla
Phone
505-913-8944
Email
doreen.padilla@quantumsantafe.com
First Name & Middle Initial & Last Name & Degree
Karen LoRusso, MD
Facility Name
Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Brigham
Phone
252-744-4924
Email
brighamd16@ecu.edu
First Name & Middle Initial & Last Name & Degree
Darla Liles, MD
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Withdrawn
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Shoup
Phone
419-214-4236
Email
PShoup@toledoclinic.com
First Name & Middle Initial & Last Name & Degree
Rex Mowat, MD
Facility Name
Allegheny Health Network (AHN) West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Pershing
Phone
412-578-5987
Email
diane.radeshak@ahn.org
First Name & Middle Initial & Last Name & Degree
Rich Wonder
Phone
412-578-4492
Email
Rich.Wonder@ahn.org
First Name & Middle Initial & Last Name & Degree
Yazan Samhouri, MD
Facility Name
Reading Hospital - McGlinn Cancer Institute
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Miller
Phone
484-628-8549
Email
Barbara.miller@towerhealth.org
First Name & Middle Initial & Last Name & Degree
Terrence Cescon, MD
Facility Name
Prairie Lakes Health Care System
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Hoare
Phone
+61 481 910 999
Email
christine.hoare@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Pratyush Giri, MD
Facility Name
Epworth Freemasons Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Barlas, MD
Phone
+61 3 9516 2374
Email
Connie.barlas@epworth.org.au
First Name & Middle Initial & Last Name & Degree
Costas Yannakou, MD
Facility Name
Box Hill Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Arnold
Phone
+61 3 9094 9516
Email
liz.arnold@monash.edu
First Name & Middle Initial & Last Name & Degree
Denise Lee, MD
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Bayley
Phone
+61 2 8890 7219
Email
Angela.bayley@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
Amanda Johnston, MD
Facility Name
Saskatoon Cancer Center
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7H 4H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Glum
Phone
306-655-1896
Email
jonathan.glum@saskcancer.ca
First Name & Middle Initial & Last Name & Degree
Mark Bosch, MD
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Edouart
Phone
01 48 95 75 05
Email
geoffrey.edouart@aphp.fr
First Name & Middle Initial & Last Name & Degree
Thorsten Braun, MD
Facility Name
Centre d'Oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Lelu
Phone
03 55 68 55 18
Email
t.lelu@ilcgroupe.fr
First Name & Middle Initial & Last Name & Degree
Serge Bologna, MD
Facility Name
Hôpital Privé du Confluent
City
Nantes
ZIP/Postal Code
44277
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Hugon
Phone
02 28 27 21 72
Email
NATHALIE.HUGON@groupeconfluent.fr
First Name & Middle Initial & Last Name & Degree
Sophie Sadot-Lebouvier, MD
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalila Wakrim
Phone
04 92 03 14 42
Email
dalila.wakrim@nice.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Peyrade, MD
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Vekhoff, MD
Phone
01 49 28 34 29
Email
anne.vekhoff@aphp.fr
First Name & Middle Initial & Last Name & Degree
Mohamad Mohty, PU-PH
Facility Name
Hôpital de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raouf Benchikh
Phone
01 84 82 70 31
Email
raouf.benchikh@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sylvain Choquet, MD
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohan Demay
Phone
01 44 49 46 57
Email
yohan.demay@aphp.fr
First Name & Middle Initial & Last Name & Degree
Adélaïde Duperray
Phone
01 44 49 52 03
Email
adelaide.duperray@aphp.fr
First Name & Middle Initial & Last Name & Degree
Morgane Cheminant, MD
Facility Name
CHU Bordeaux- Hôpital Haut Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souheyla Bouteman
Phone
05 57 65 60 18
Email
souheyla.boutemane@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Nathalie Franzl
Phone
05 57 62 33 23
Email
nathalie.franzl@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Francois-Xavier Gros, MD
Facility Name
Centre Hospitalier de Périgueux
City
Périgueux
ZIP/Postal Code
24019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Jouinot
Phone
05 53 45 29 73
Email
aude.jouinot@ch-perigueux.fr
First Name & Middle Initial & Last Name & Degree
Claire Calmettes, MD
Facility Name
Centre Hospitalier de Saint-Quentin
City
Saint-Quentin
ZIP/Postal Code
02321
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelkrim Boulanouar
Phone
03 23 06 78 61
Email
a.boulanouar@ch-stquentin.fr
First Name & Middle Initial & Last Name & Degree
Réda Garidi, MD
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Mezei, MD
Phone
+36 30 657 5238
Email
gmezei@gmail.com
First Name & Middle Initial & Last Name & Degree
Árpád ILLÉS, MD
Facility Name
SzSzBM Korhazak es Egyetemi Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt HORVÁTH
Phone
+36 20 998 5123
Email
horvathzsolt00@gmail.com
First Name & Middle Initial & Last Name & Degree
László REJTŐ, MD
Facility Name
North Shore Hospital
City
Auckland
State/Province
Auckland Province
ZIP/Postal Code
0622
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Leitch, MD
Phone
64 9 486 8900
Email
Sophie.Leitch@waitematadhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Sophie Leitch, MD
Facility Name
Palmerston North Hospital
City
Palmerston North
State/Province
Manawatu
ZIP/Postal Code
4414
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RCTS Clinical Trials Unit
Phone
+64 6 350 8254
Email
jacqui.toms@midcentraldhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Dixon Grant, MD
Facility Name
Szpitale Pomorskie Sp. z o. o.
City
Gdynia
ZIP/Postal Code
85-519
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Cicha
Phone
+48 58 726 0380
Email
info.onkocwbk@szpitalepomorskie.eu
First Name & Middle Initial & Last Name & Degree
Wanda Knopińska-Posłuszny, MD
Facility Name
Wojewódzki Szpital Specjalistyczny w Legnicy
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadwiga Holodja, MD
Phone
505-149-579
Email
jadwiga.holojda@szpital.legnica.pl
First Name & Middle Initial & Last Name & Degree
Barbara Boruta-Pankowska
Phone
668-446-646
Email
barbara.pankowska@szpital.legnica.pl
First Name & Middle Initial & Last Name & Degree
Jadwiga Holodja, MD
Facility Name
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakub Zawadzki
Phone
+48 89-539-87-56
Email
jakub.zawadzki@poliklinika.net
First Name & Middle Initial & Last Name & Degree
Marta Witowska
Phone
+48 89-539-87-56
Email
marta.lapiejko@poliklinika.net
First Name & Middle Initial & Last Name & Degree
Janusz Hałka, MD
Facility Name
Centrum Medyczne Pratia Poznań
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Szymalak
Phone
512-491-461
Email
natalia.bigott@pratia.com
First Name & Middle Initial & Last Name & Degree
Lukasz Pruchniewski, MD
Facility Name
Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pich
Phone
+ 48 22 546 2223
Email
anna.pich@pib-nio.pl
First Name & Middle Initial & Last Name & Degree
Jan Walewski, MD
Facility Name
Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Rosoiu, MD
Phone
+4078 3163 970
Email
mirela.rosoiu@arensia-em.com
First Name & Middle Initial & Last Name & Degree
Laura-Aifer Calustian, MD
Facility Name
The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliia Moskalenko
Phone
+4073 5888 501
Email
nataliia.moskalenko@arensia-em.com
First Name & Middle Initial & Last Name & Degree
Hanna Varytska
Phone
+4076 0818 421
Email
hanna.varytska@arensia-em.com
First Name & Middle Initial & Last Name & Degree
Delia Dima, MD
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darko Antic, MD
Phone
+381 63 634 747
Email
darko.antic1510976@gmail.com
First Name & Middle Initial & Last Name & Degree
Nikica Sabljic
Phone
+381 61 192 46 68
Email
nsabljic19@gmail.com
First Name & Middle Initial & Last Name & Degree
Biljana Mihaljevic, MD
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Dragovic
Phone
+381 65 325 97 65
Email
anadragovicana@gmail.com
First Name & Middle Initial & Last Name & Degree
Predrag Djurdjevic, MD
Facility Name
Oncology Institute of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dijana Zekic
Phone
+381 64 08 00 868
Email
klinicka.istrazivanja@onk.ns.ac.rs
First Name & Middle Initial & Last Name & Degree
Lazar Popovic, MD
Facility Name
Clinical Hospital Center Zemun
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Bibic
Phone
+381 60 511 10 45
Email
tmedic83@gmail.com
First Name & Middle Initial & Last Name & Degree
Zorica Cvetkovic, MD
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Pérez
Phone
+34 93 291 90 00
Ext
8538
Email
nperezg@santpau.cat
First Name & Middle Initial & Last Name & Degree
Javier Briones, MD
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Alcaraz
Phone
+34 947281800
Ext
36078
Email
ralcaraz@hubu.es
First Name & Middle Initial & Last Name & Degree
Jorge Labrado Gómez, MD
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocío Jiménez
Phone
+34 95 501 32 77
Email
rociojimenezalvarez@gmail.com
First Name & Middle Initial & Last Name & Degree
Fatima de la Cruz Vicente, MD
12. IPD Sharing Statement
Learn more about this trial
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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