DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)
Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
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
Experimental
Experimental
Arm 1: DPX-Survivac, pembrolizumab, CPA
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. 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.