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

Last updated: April 5, 2023
Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT04920617
P1605-SUR-D23
KEYNOTE-C54
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 2may be enrolled with Medical Monitor approval.
  • Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World HealthOrganization classification including DLBCL NOS high-grade B-cell lymphoma with MYCand BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and Tcell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolentlymphoma (except for Richter's transformation) are eligible.
  • Subjects must have progressive disease following at least two (2) lines of priorsystemic therapy for DLBCL; prior treatment must have included an anthracycline andrituximab (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.

Exclusion

Key Exclusion Criteria:

  • Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatousmeningitis
  • 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 thathas required systemic treatment in the past 2 years
  • Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, orHIV may be eligible)
  • Prior history of malignancy other than eligible lymphoma sub-types, unless the subjecthas been free of the disease for ≥ 2 years prior to the start of study treatment

Study Design

Total Participants: 102
Study Start date:
June 18, 2021
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Melbourne, Victoria 3128
    Australia

    Active - Recruiting

  • Epworth Freemasons Hospital

    Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, 2145
    Australia

    Active - Recruiting

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan S7H 4H4
    Canada

    Active - Recruiting

  • Hôpital Avicenne

    Bobigny, 93000
    France

    Active - Recruiting

  • Centre d'Oncologie de Gentilly

    Nancy, 54000
    France

    Active - Recruiting

  • Hôpital Privé du Confluent

    Nantes, 44277
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

  • Hôpital Necker

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Saint-Antoine

    Paris, 75012
    France

    Active - Recruiting

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • CHU Bordeaux- Hôpital Haut Lévêque

    Pessac, 33600
    France

    Active - Recruiting

  • Centre Hospitalier de Périgueux

    Périgueux, 24019
    France

    Active - Recruiting

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321
    France

    Active - Recruiting

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • SzSzBM Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400
    Hungary

    Active - Recruiting

  • North Shore Hospital

    Auckland, Auckland Province 0622
    New Zealand

    Active - Recruiting

  • Palmerston North Hospital

    Palmerston North, Manawatu 4414
    New Zealand

    Active - Recruiting

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 85-519
    Poland

    Active - Recruiting

  • Wojewódzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220
    Poland

    Active - Recruiting

  • SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Poznań

    Skórzewo, 60-185
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie

    Warszawa, 02-781
    Poland

    Active - Recruiting

  • Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"

    Bucharest, 022328
    Romania

    Active - Recruiting

  • The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.

    Cluj-Napoca, 400015
    Romania

    Active - Recruiting

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Oncology Institute of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Active - Recruiting

  • Clinical Hospital Center Zemun

    Zemun, 11080
    Serbia

    Active - Recruiting

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Compassionate Cancer Care Medical Group

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Boca Raton Regional Hospital

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • BRCR Medical Center Inc.

    Hollywood, Florida 33021
    United States

    Site Not Available

  • BRCR Medical Center Inc.

    Plantation, Florida 33322
    United States

    Site Not Available

  • Comprehensive Hematology and Oncology

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Tulane Cancer Center Office of Clinical Research

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico 87505
    United States

    Active - Recruiting

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • Toledo Clinic Cancer Center

    Toledo, Ohio 43623
    United States

    Active - Recruiting

  • University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Allegheny Health Network (AHN) West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Reading Hospital - McGlinn Cancer Institute

    West Reading, Pennsylvania 19611
    United States

    Active - Recruiting

  • Prairie Lakes Health Care System

    Watertown, South Dakota 57201
    United States

    Site Not Available

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