Ireland
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Recruiting Phase 2

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

NCT04920617 · tracked via the Priya Life Science France tracker
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Phase
Phase 2
Started
2021-06-18
Last updated
2023-04-07

Condition(s) studied

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

Investigational drug(s) / intervention(s)

DPX-Survivac →Pembrolizumab →CPA →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective response rate (ORR) in each of the study arms — Approximately 24 months
    Centrally evaluated using Lugano (2014)

Trial sites (50)

FacilityCityRegionStatus
Compassionate Cancer Care Medical Group Fountain Valley California Recruiting
Boca Raton Regional Hospital Boca Raton Florida Withdrawn
BRCR Medical Center Inc. Hollywood Florida Withdrawn
BRCR Medical Center Inc. Plantation Florida Withdrawn
Comprehensive Hematology and Oncology St. Petersburg Florida Withdrawn
Blood and Marrow Transplant Group of Georgia Atlanta Georgia Recruiting
Indiana University Health Melvin and Bren Simon Cancer Center Indianapolis Indiana Recruiting
Tulane Cancer Center Office of Clinical Research New Orleans Louisiana Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists Omaha Nebraska Recruiting
Christus St. Vincent Regional Cancer Center Santa Fe New Mexico Recruiting
Brody School of Medicine at East Carolina University Greenville North Carolina Recruiting
Gabrail Cancer Center Research Canton Ohio Withdrawn
University of Toledo Medical Center Toledo Ohio Withdrawn
Toledo Clinic Cancer Center Toledo Ohio Recruiting
Allegheny Health Network (AHN) West Penn Hospital Pittsburgh Pennsylvania Recruiting
Reading Hospital - McGlinn Cancer Institute West Reading Pennsylvania Recruiting
Prairie Lakes Health Care System Watertown South Dakota Withdrawn
Royal Adelaide Hospital Adelaide South Australia Recruiting
Epworth Freemasons Hospital Melbourne Victoria Recruiting
Box Hill Hospital Melbourne Victoria Recruiting
Westmead Hospital Westmead Australia Recruiting
Saskatoon Cancer Center Saskatoon Saskatchewan Recruiting
Hôpital Avicenne Bobigny France Recruiting
Centre d'Oncologie de Gentilly Nancy France Recruiting
Hôpital Privé du Confluent Nantes France Recruiting
Centre Antoine Lacassagne Nice France Recruiting
Hôpital Saint-Antoine Paris France Recruiting
Hôpital de la Pitié-Salpêtrière Paris France Recruiting
Hôpital Necker Paris France Recruiting
CHU Bordeaux- Hôpital Haut Lévêque Pessac France Recruiting
Centre Hospitalier de Périgueux Périgueux France Recruiting
Centre Hospitalier de Saint-Quentin Saint-Quentin France Recruiting
Debreceni Egyetem Klinikai Központ Debrecen Hungary Recruiting
SzSzBM Korhazak es Egyetemi Oktatokorhaz Nyíregyháza Hungary Recruiting
North Shore Hospital Auckland Auckland Province Recruiting
Palmerston North Hospital Palmerston North Manawatu Recruiting
Szpitale Pomorskie Sp. z o. o. Gdynia Poland Recruiting
Wojewódzki Szpital Specjalistyczny w Legnicy Legnica Poland Recruiting
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie Olsztyn Poland Recruiting
Centrum Medyczne Pratia Poznań Skórzewo Poland Recruiting

+ 10 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04920617 on ClinicalTrials.gov ↗ ← All trials in France