Status:
RECRUITING
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Relapsed Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 refr...
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 refr...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04920617
Start Date
June 18 2021
End Date
April 1 2025
Last Update
April 7 2023
Active Locations (50)
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1
Compassionate Cancer Care Medical Group
Fountain Valley, California, United States, 92708
2
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
3
BRCR Medical Center Inc.
Hollywood, Florida, United States, 33021
4
BRCR Medical Center Inc.
Plantation, Florida, United States, 33322