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Name: 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)
Creator: ImmunoVaccine Technologies, Inc. (IMV Inc.)
Published: 2021-06-10
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT04920617 (VITALIZE) for Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE) Phase 2 102 Randomized Open-Label

Recruiting

Clinical Trial NCT04920617 (VITALIZE) is designed to study Treatment for Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma. It is a Phase 2 interventional study that is recruiting, having started on 18 June 2021, with plans to enroll 102 participants. Led by ImmunoVaccine Technologies, Inc. (IMV Inc.), it is expected to complete by 1 April 2025. The latest data from ClinicalTrials.gov was last updated on 7 April 2023.

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

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 pembroli...

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)

Conditions

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

Other Study IDs

VITALIZE
P1605-SUR-D23
KEYNOTE-C54 (Other Identifier) (Merck Sharp & Dohme Corp.)

NCT ID Number

NCT04920617

Start Date (Actual)

2021-06-18

Last Update Posted

2023-04-07

Completion Date (Estimated)

2025-04

Enrollment (Estimated)

102

Study Type

Interventional

PHASE

Phase 2

Status

Recruiting

Keywords

Immunotherapy
T cell activation
DLBCL
Anti-PD-1
CAR-T ineligible
ASCT ineligible

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalArm 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
ExperimentalArm 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms		Approximately 24 months
Duration of response (DOR) in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Time to response in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Progression-Free Survival in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 48 months
Disease control rate (DCR) in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Complete response (CR) rate in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
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).	Approximately 24 months
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.	Approximately 24 months

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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.

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

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Merck Sharp & Dohme LLC

No contact data.

50 Study Locations in 10 Countries

Australia

South Australia

Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia

Christine Hoare, Contact, +61 481 910 999, [email protected]

Pratyush Giri, MD, Principal Investigator

Recruiting

Victoria

Epworth Freemasons Hospital, Melbourne, Victoria, 3002, Australia

Connie Barlas, MD, Contact, +61 3 9516 2374, [email protected]

Costas Yannakou, MD, Principal Investigator

Recruiting

Box Hill Hospital, Melbourne, Victoria, 3128, Australia

Liz Arnold, Contact, +61 3 9094 9516, [email protected]

Denise Lee, MD, Principal Investigator

Recruiting

Westmead Hospital, Westmead, 2145, Australia

Angela Bayley, Contact, +61 2 8890 7219, [email protected]

Amanda Johnston, MD, Principal Investigator

Recruiting

New Zealand

Auckland Province

North Shore Hospital, Auckland, Auckland Province, 0622, New Zealand

Sophie Leitch, MD, Contact, 64 9 486 8900, [email protected]

Sophie Leitch, MD, Principal Investigator

Recruiting

Manawatu

Palmerston North Hospital, Palmerston North, Manawatu, 4414, New Zealand

RCTS Clinical Trials Unit, Contact, +64 6 350 8254, [email protected]

Dixon Grant, MD, Principal Investigator

Recruiting

United States

California

Compassionate Cancer Care Medical Group, Fountain Valley, California, 92708, United States

Eric Lee, MD, Contact, 714-698-0300, [email protected]

Haresh Jhangiani, MD, Contact, 714-698-0300, [email protected]

Eric Lee, MD, Principal Investigator

Recruiting

Florida

Boca Raton Regional Hospital, Boca Raton, Florida, 33486, United States

Withdrawn

BRCR Medical Center Inc., Hollywood, Florida, 33021, United States

Withdrawn

BRCR Medical Center Inc., Plantation, Florida, 33322, United States

Withdrawn

Comprehensive Hematology and Oncology, St. Petersburg, Florida, 33709, United States

Withdrawn

Georgia

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, 30342, United States

Stacey Brown, Contact, 404-780-7965, [email protected]

Melhem Solh, MD, Contact, 404-255-1930, [email protected]

Melhem Solh, MD, Principal Investigator

Recruiting

Indiana

Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States

Jill Weisenbach, Contact, 317-274-2848, [email protected]

Michael Robertson, MD, Principal Investigator

Recruiting

Louisiana

Tulane Cancer Center Office of Clinical Research, New Orleans, Louisiana, 70112, United States

Leta Ko, Contact, 504-988-6120, [email protected]

Nakhle Saba, MD, Principal Investigator

Recruiting

Nebraska

Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, 68130, United States

Scott Degenhardt, Contact, 402-691-5257, [email protected]

Stefano Tarantolo, MD, Principal Investigator

Recruiting

New Mexico

Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, 87505, United States

Doreen Padilla, Contact, 505-913-8944, [email protected]

Karen LoRusso, MD, Principal Investigator

Recruiting

North Carolina

Brody School of Medicine at East Carolina University, Greenville, North Carolina, 27834, United States

Denise Brigham, Contact, 252-744-4924, [email protected]

Darla Liles, MD, Principal Investigator

Recruiting

Ohio

Gabrail Cancer Center Research, Canton, Ohio, 44718, United States

Withdrawn

University of Toledo Medical Center, Toledo, Ohio, 43614, United States

Withdrawn

Toledo Clinic Cancer Center, Toledo, Ohio, 43623, United States

Pam Shoup, Contact, 419-214-4236, [email protected]

Rex Mowat, MD, Principal Investigator

Recruiting

Pennsylvania

Allegheny Health Network (AHN) West Penn Hospital, Pittsburgh, Pennsylvania, 15224, United States

Diane Pershing, Contact, 412-578-5987, [email protected]

Rich Wonder, Contact, 412-578-4492, [email protected]

Yazan Samhouri, MD, Principal Investigator

Recruiting

Reading Hospital - McGlinn Cancer Institute, West Reading, Pennsylvania, 19611, United States

Barbara Miller, Contact, 484-628-8549, [email protected]

Terrence Cescon, MD, Principal Investigator

Recruiting

South Dakota

Prairie Lakes Health Care System, Watertown, South Dakota, 57201, United States

Withdrawn

Canada

Saskatchewan

Saskatoon Cancer Center, Saskatoon, Saskatchewan, S7H 4H4, Canada

Jonathan Glum, Contact, 306-655-1896, [email protected]

Mark Bosch, MD, Principal Investigator

Recruiting

France

Hôpital Avicenne, Bobigny, 93000, France

Geoffrey Edouart, Contact, 01 48 95 75 05, [email protected]

Thorsten Braun, MD, Principal Investigator

Recruiting

Centre d'Oncologie de Gentilly, Nancy, 54000, France

Thomas Lelu, Contact, 03 55 68 55 18, [email protected]

Serge Bologna, MD, Principal Investigator

Recruiting

Hôpital Privé du Confluent, Nantes, 44277, France

Nathalie Hugon, Contact, 02 28 27 21 72, [email protected]

Sophie Sadot-Lebouvier, MD, Principal Investigator

Recruiting

Centre Antoine Lacassagne, Nice, 06189, France

Dalila Wakrim, Contact, 04 92 03 14 42, [email protected]

Frédéric Peyrade, MD, Principal Investigator

Recruiting

Hôpital Saint-Antoine, Paris, 75012, France

Anne Vekhoff, MD, Contact, 01 49 28 34 29, [email protected]

Mohamad Mohty, PU-PH, Principal Investigator

Recruiting

Hôpital de la Pitié-Salpêtrière, Paris, 75013, France

Raouf Benchikh, Contact, 01 84 82 70 31, [email protected]

Sylvain Choquet, MD, Principal Investigator

Recruiting

Hôpital Necker, Paris, 75015, France

Yohan Demay, Contact, 01 44 49 46 57, [email protected]

Adélaïde Duperray, Contact, 01 44 49 52 03, [email protected]

Morgane Cheminant, MD, Principal Investigator

Recruiting

CHU Bordeaux- Hôpital Haut Lévêque, Pessac, 33600, France

Souheyla Bouteman, Contact, 05 57 65 60 18, [email protected]

Nathalie Franzl, Contact, 05 57 62 33 23, [email protected]

Francois-Xavier Gros, MD, Principal Investigator

Recruiting

Centre Hospitalier de Périgueux, Périgueux, 24019, France

Aude Jouinot, Contact, 05 53 45 29 73, [email protected]

Claire Calmettes, MD, Principal Investigator

Recruiting

Centre Hospitalier de Saint-Quentin, Saint-Quentin, 02321, France

Abdelkrim Boulanouar, Contact, 03 23 06 78 61, [email protected]

Réda Garidi, MD, Principal Investigator

Recruiting

Hungary

Debreceni Egyetem Klinikai Központ, Debrecen, 4032, Hungary

Gabriella Mezei, MD, Contact, +36 30 657 5238, [email protected]

Árpád ILLÉS, MD, Principal Investigator

Recruiting

SzSzBM Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza, 4400, Hungary

Zsolt HORVÁTH, Contact, +36 20 998 5123, [email protected]

László REJTŐ, MD, Principal Investigator

Recruiting

Poland

Szpitale Pomorskie Sp. z o. o., Gdynia, 85-519, Poland

Karolina Cicha, Contact, +48 58 726 0380, [email protected]

Wanda Knopińska-Posłuszny, MD, Principal Investigator

Recruiting

Wojewódzki Szpital Specjalistyczny w Legnicy, Legnica, 59-220, Poland

Jadwiga Holodja, MD, Contact, 505-149-579, [email protected]

Barbara Boruta-Pankowska, Contact, 668-446-646, [email protected]

Jadwiga Holodja, MD, Principal Investigator

Recruiting

SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, 10-228, Poland

Jakub Zawadzki, Contact, +48 89-539-87-56, [email protected]

Marta Witowska, Contact, +48 89-539-87-56, [email protected]

Janusz Hałka, MD, Principal Investigator

Recruiting

Centrum Medyczne Pratia Poznań, Skórzewo, 60-185, Poland

Natalia Szymalak, Contact, 512-491-461, [email protected]

Lukasz Pruchniewski, MD, Principal Investigator

Recruiting

Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie, Warsaw, 02-781, Poland

Anna Pich, Contact, + 48 22 546 2223, [email protected]

Jan Walewski, MD, Principal Investigator

Recruiting

Romania

Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu", Bucharest, 022328, Romania

Monica Rosoiu, MD, Contact, +4078 3163 970, [email protected]

Laura-Aifer Calustian, MD, Principal Investigator

Recruiting

The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H., Cluj-Napoca, 400015, Romania

Nataliia Moskalenko, Contact, +4073 5888 501, [email protected]

Hanna Varytska, Contact, +4076 0818 421, [email protected]

Delia Dima, MD, Principal Investigator

Recruiting

Serbia

University Clinical Center of Serbia, Belgrade, 11000, Serbia

Darko Antic, MD, Contact, +381 63 634 747, [email protected]

Nikica Sabljic, Contact, +381 61 192 46 68, [email protected]

Biljana Mihaljevic, MD, Principal Investigator

Recruiting

Oncology Institute of Vojvodina, Kamenitz, 21204, Serbia

Dijana Zekic, Contact, +381 64 08 00 868, [email protected]

Lazar Popovic, MD, Principal Investigator

Recruiting

University Clinical Center Kragujevac, Kragujevac, 34000, Serbia

Ana Dragovic, Contact, +381 65 325 97 65, [email protected]

Predrag Djurdjevic, MD, Principal Investigator

Recruiting

Clinical Hospital Center Zemun, Zemun, 11080, Serbia

Tamara Bibic, Contact, +381 60 511 10 45, [email protected]

Zorica Cvetkovic, MD, Principal Investigator

Recruiting

Spain

Hospital Santa Creu i Sant Pau, Barcelona, 08041, Spain

Nuria Pérez, Contact, +34 93 291 90 00, [email protected]

Javier Briones, MD, Principal Investigator

Recruiting

Hospital Universitario de Burgos, Burgos, 09006, Spain

Raquel Alcaraz, Contact, +34 947281800, [email protected]

Jorge Labrado Gómez, MD, Principal Investigator

Recruiting

Hospital Universitario Virgen del Rocío, Seville, 41013, Spain

Rocío Jiménez, Contact, +34 95 501 32 77, [email protected]

Fatima de la Cruz Vicente, MD, Principal Investigator

Recruiting

DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE) Phase 2 102 Randomized Open-Label

Inclusion Criteria

Exclusion Criteria