Recruiting
Phase 2

DPX-Survivac & Pembrolizumab

Sponsor:

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Code:

NCT04920617

Conditions

Relapsed Diffuse Large B-cell Lymphoma

Refractory Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DPX-Survivac

Pembrolizumab

CPA

Study Details

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.

Conditions

Relapsed Diffuse Large B-cell Lymphoma

Refractory Diffuse Large B-cell Lymphoma

Study ID

NCT04920617

Start date

Jun 18, 2021

Status verified date

Aug, 2022

Completion date

Apr, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 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.

experimental: 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. Subjects randomized to Arm 2 will not receive CPA.

Interventions

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

Primary outcome measure

  • Objective response rate (ORR) in each of the study arms [ Time Frame: Approximately 24 months ]

Central Contacts and Locations

Locations

Compassionate Cancer Care Medical Group

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Eric Lee, MD

714-698-0300ericlee@compcancercare.com

Haresh Jhangiani, MD

714-698-0300hjhangiani1@gmail.com

Principal Investigator:

Eric Lee, MD

Blood and Marrow Transplant Group of Georgia

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Stacey Brown

404-780-7965Stacey.brown@northside.com

Melhem Solh, MD

404-255-1930msolh@bmtga.com

Principal Investigator:

Melhem Solh, MD

Indiana University Health Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jill Weisenbach

317-274-2848jweisenb@iupui.edu

Principal Investigator:

Michael Robertson, MD

Tulane Cancer Center Office of Clinical Research

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Leta Ko

504-988-6120lko@tulane.edu

Principal Investigator:

Nakhle Saba, MD

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Scott Degenhardt

402-691-5257sdegenhardt@NebraskaCancer.com

Principal Investigator:

Stefano Tarantolo, MD

Christus St. Vincent Regional Cancer Center

Recruiting

Santa Fe, New Mexico, United States, 87505

Contacts

Doreen Padilla

505-913-8944doreen.padilla@quantumsantafe.com

Principal Investigator:

Karen LoRusso, MD

Brody School of Medicine at East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Denise Brigham

252-744-4924brighamd16@ecu.edu

Principal Investigator:

Darla Liles, MD

Toledo Clinic Cancer Center

Recruiting

Toledo, Ohio, United States, 43623

Contacts

Pam Shoup

419-214-4236PShoup@toledoclinic.com

Principal Investigator:

Rex Mowat, MD

Allegheny Health Network (AHN) West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Diane Pershing

412-578-5987diane.radeshak@ahn.org

Rich Wonder

412-578-4492Rich.Wonder@ahn.org

Principal Investigator:

Yazan Samhouri, MD

Reading Hospital - McGlinn Cancer Institute

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Barbara Miller

484-628-8549Barbara.miller@towerhealth.org

Principal Investigator:

Terrence Cescon, MD

Saskatoon Cancer Center

Recruiting

Saskatoon, Saskatchewan, Canada, S7H 4H4

Contacts

Jonathan Glum

306-655-1896jonathan.glum@saskcancer.ca

Principal Investigator:

Mark Bosch, MD

More Information

Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Last update posted

Apr 7, 2023

Last verified

Aug, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ImmunoVaccine Technologies, Inc. (IMV Inc.) on 2023-04-07.