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Recruiting

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

NCT04920617 · ImmunoVaccine Technologies, Inc. (IMV Inc.)
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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)
About this study
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
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
Study design
Enrollment target: 102 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-06-18
Estimated completion: 2025-04
Last updated: 2023-04-07
Interventions
Drug: DPX-SurvivacDrug: PembrolizumabDrug: CPA
Primary outcomes
  • Objective response rate (ORR) in each of the study arms (Approximately 24 months)
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.) · industry
With: Merck Sharp & Dohme LLC
All locations (50)
Compassionate Cancer Care Medical GroupRecruiting
Fountain Valley, California, United States
Boca Raton Regional HospitalWithdrawn
Boca Raton, Florida, United States
BRCR Medical Center Inc.Withdrawn
Hollywood, Florida, United States
BRCR Medical Center Inc.Withdrawn
Plantation, Florida, United States
Comprehensive Hematology and OncologyWithdrawn
St. Petersburg, Florida, United States
Blood and Marrow Transplant Group of GeorgiaRecruiting
Atlanta, Georgia, United States
Indiana University Health Melvin and Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
Tulane Cancer Center Office of Clinical ResearchRecruiting
New Orleans, Louisiana, United States
Oncology Hematology West, PC dba Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Christus St. Vincent Regional Cancer CenterRecruiting
Santa Fe, New Mexico, United States
Brody School of Medicine at East Carolina UniversityRecruiting
Greenville, North Carolina, United States
Gabrail Cancer Center ResearchWithdrawn
Canton, Ohio, United States
University of Toledo Medical CenterWithdrawn
Toledo, Ohio, United States
Toledo Clinic Cancer CenterRecruiting
Toledo, Ohio, United States
Allegheny Health Network (AHN) West Penn HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Reading Hospital - McGlinn Cancer InstituteRecruiting
West Reading, Pennsylvania, United States
Prairie Lakes Health Care SystemWithdrawn
Watertown, South Dakota, United States
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Epworth Freemasons HospitalRecruiting
Melbourne, Victoria, Australia
Box Hill HospitalRecruiting
Melbourne, Victoria, Australia
Westmead HospitalRecruiting
Westmead, Australia
Saskatoon Cancer CenterRecruiting
Saskatoon, Saskatchewan, Canada
Hôpital AvicenneRecruiting
Bobigny, France
Centre d'Oncologie de GentillyRecruiting
Nancy, France
Hôpital Privé du ConfluentRecruiting
Nantes, France
Centre Antoine LacassagneRecruiting
Nice, France
Hôpital Saint-AntoineRecruiting
Paris, France
Hôpital de la Pitié-SalpêtrièreRecruiting
Paris, France
Hôpital NeckerRecruiting
Paris, France
CHU Bordeaux- Hôpital Haut LévêqueRecruiting
Pessac, France
Centre Hospitalier de PérigueuxRecruiting
Périgueux, France
Centre Hospitalier de Saint-QuentinRecruiting
Saint-Quentin, France
Debreceni Egyetem Klinikai KözpontRecruiting
Debrecen, Hungary
SzSzBM Korhazak es Egyetemi OktatokorhazRecruiting
Nyíregyháza, Hungary
North Shore HospitalRecruiting
Auckland, Auckland Province, New Zealand
Palmerston North HospitalRecruiting
Palmerston North, Manawatu, New Zealand
Szpitale Pomorskie Sp. z o. o.Recruiting
Gdynia, Poland
Wojewódzki Szpital Specjalistyczny w LegnicyRecruiting
Legnica, Poland
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w OlsztynieRecruiting
Olsztyn, Poland
Centrum Medyczne Pratia PoznańRecruiting
Skórzewo, Poland
Narodowy Instytut Onkologii im. Marii, Skłodowskiej-CurieRecruiting
Warsaw, Poland
Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"Recruiting
Bucharest, Romania
The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.Recruiting
Cluj-Napoca, Romania
University Clinical Center of SerbiaRecruiting
Belgrade, Serbia
Oncology Institute of VojvodinaRecruiting
Kamenitz, Serbia
University Clinical Center KragujevacRecruiting
Kragujevac, Serbia
Clinical Hospital Center ZemunRecruiting
Zemun, Serbia
Hospital Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Universitario de BurgosRecruiting
Burgos, Spain
Hospital Universitario Virgen del RocíoRecruiting
Seville, Spain
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma · TrialPath