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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Study ID
NCT04920617
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Refractory Diffuse Large B-cell Lymphoma
  • Relapsed Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DPX-Survivac — DRUG
    SC injection on D7 and D28, then every 8 weeks
  • Pembrolizumab — DRUG
    IV infusion every 3 weeks
  • CPA — DRUG
    50 mg twice daily, week on then week off

Study Details

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.

Key Dates

Start date
Jun 18, 2021
Status verified
Aug 2022
Primary completion
Oct 31, 2024
Completion
Apr 30, 2025

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (17)

FacilityCityStateZIPSite coordinators
Compassionate Cancer Care Medical GroupFountain ValleyCalifornia92708
Eric Lee, MD
[email protected]
714-698-0300
Haresh Jhangiani, MD
[email protected]
714-698-0300
Eric Lee, MD (PRINCIPAL_INVESTIGATOR)
Boca Raton Regional HospitalBoca RatonFlorida33486-
BRCR Medical Center Inc.HollywoodFlorida33021-
BRCR Medical Center Inc.PlantationFlorida33322-
Comprehensive Hematology and OncologySt. PetersburgFlorida33709-
Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgia30342
Stacey Brown
[email protected]
404-780-7965
Melhem Solh, MD
[email protected]
404-255-1930
Melhem Solh, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202
Jill Weisenbach
[email protected]
317-274-2848
Michael Robertson, MD (PRINCIPAL_INVESTIGATOR)
Tulane Cancer Center Office of Clinical ResearchNew OrleansLouisiana70112
Leta Ko
[email protected]
504-988-6120
Nakhle Saba, MD (PRINCIPAL_INVESTIGATOR)
Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmahaNebraska68130
Scott Degenhardt
[email protected]
402-691-5257
Stefano Tarantolo, MD (PRINCIPAL_INVESTIGATOR)
Christus St. Vincent Regional Cancer CenterSanta FeNew Mexico87505
Doreen Padilla
[email protected]
505-913-8944
Karen LoRusso, MD (PRINCIPAL_INVESTIGATOR)
Brody School of Medicine at East Carolina UniversityGreenvilleNorth Carolina27834
Denise Brigham
[email protected]
252-744-4924
Darla Liles, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Center ResearchCantonOhio44718-
Toledo Clinic Cancer CenterToledoOhio43623
Pam Shoup
[email protected]
419-214-4236
Rex Mowat, MD (PRINCIPAL_INVESTIGATOR)
University of Toledo Medical CenterToledoOhio43614-
Allegheny Health Network (AHN) West Penn HospitalPittsburghPennsylvania15224
Diane Pershing
[email protected]
412-578-5987
Rich Wonder
[email protected]
412-578-4492
Yazan Samhouri, MD (PRINCIPAL_INVESTIGATOR)
Reading Hospital - McGlinn Cancer InstituteWest ReadingPennsylvania19611
Barbara Miller
[email protected]
484-628-8549
Terrence Cescon, MD (PRINCIPAL_INVESTIGATOR)
Prairie Lakes Health Care SystemWatertownSouth Dakota57201-

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Compassionate Cancer Care Medical Group· Fountain Valley, CABoca Raton Regional Hospital· Boca Raton, FLBRCR Medical Center Inc.· Hollywood, FLBRCR Medical Center Inc.· Plantation, FLComprehensive Hematology and Oncology· St. Petersburg, FLBlood and Marrow Transplant Group of Georgia· Atlanta, GA

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