A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)
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.
Detailed 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.
Arms & interventions
- DrugDPX-Survivac
SC injection on D7 and D28, then every 8 weeks
- DrugPembrolizumab
IV infusion every 3 weeks
- DrugCPA
50 mg twice daily, week on then week off
Outcome measures
Primary
Objective response rate (ORR) in each of the study arms
Centrally evaluated using Lugano (2014)
Time frame: Approximately 24 months
Secondary
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms
Time frame: Approximately 24 months
Duration of response (DOR) in each of the study arms
Time frame: Approximately 24 months
Time to response in each of the study arms
Time frame: Approximately 24 months
Progression-Free Survival in each of the study arms
Time frame: Approximately 48 months
Disease control rate (DCR) in each of the study arms
Time frame: Approximately 24 months
Complete response (CR) rate in each of the study arms
Time frame: Approximately 24 months
Changes in Patient Reported Outcomes using the FACT-Lym Assessment
Time frame: Approximately 24 months
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment
Time frame: Approximately 24 months
Eligibility criteria
Study locations (17)
Compassionate Cancer Care Medical Group
Fountain Valley, California, 92708
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
BRCR Medical Center Inc.
Hollywood, Florida, 33021
BRCR Medical Center Inc.
Plantation, Florida, 33322
Comprehensive Hematology and Oncology
St. Petersburg, Florida, 33709
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, 70112
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Gabrail Cancer Center Research
Canton, Ohio, 44718
University of Toledo Medical Center
Toledo, Ohio, 43614
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
Allegheny Health Network (AHN) West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania, 19611
Prairie Lakes Health Care System
Watertown, South Dakota, 57201