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Trial record 4 of 10 for:    DPX-Survivac

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

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ClinicalTrials.gov Identifier: NCT04920617
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : December 5, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

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.

Condition or disease Intervention/treatment Phase
Relapsed Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma Drug: DPX-Survivac Drug: Pembrolizumab Drug: CPA Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 18, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : April 2025


Arm Intervention/treatment
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.
Drug: DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Other Name: maveropepimut-S

Drug: Pembrolizumab
IV infusion every 3 weeks
Other Names:
  • MK-3475
  • Keytruda

Drug: CPA
50 mg twice daily, week on then week off
Other Names:
  • Intermittent, low-dose cyclophosphamide
  • Procytox
  • Cytoxan

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.
Drug: DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Other Name: maveropepimut-S

Drug: Pembrolizumab
IV infusion every 3 weeks
Other Names:
  • MK-3475
  • Keytruda




Primary Outcome Measures :
  1. Objective response rate (ORR) in each of the study arms [ Time Frame: Approximately 24 months ]
    Centrally evaluated using Lugano (2014)


Secondary Outcome Measures :
  1. 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 ]
  2. Duration of response (DOR) in each of the study arms [ Time Frame: Approximately 24 months ]
    Centrally evaluated using Lugano (2014)

  3. Time to response in each of the study arms [ Time Frame: Approximately 24 months ]
    Centrally evaluated using Lugano (2014)

  4. Progression-Free Survival in each of the study arms [ Time Frame: Approximately 48 months ]
    Centrally evaluated using Lugano (2014)

  5. Disease control rate (DCR) in each of the study arms [ Time Frame: Approximately 24 months ]
    Centrally evaluated using Lugano (2014)

  6. Complete response (CR) rate in each of the study arms [ Time Frame: Approximately 24 months ]
    Centrally evaluated using Lugano (2014)

  7. Changes in Patient Reported Outcomes using the FACT-Lym Assessment [ Time Frame: Approximately 24 months ]
    The FACT-Lym is a validated questionnaire that consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale).

  8. Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment [ Time Frame: Approximately 24 months ]
    The EQ-5D-5L is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression.


Other Outcome Measures:
  1. Objective Response Rate (ORR) based on PD-L1 expression [ Time Frame: Approximately 24 months ]
    Centrally evaluated using Lugano (2014) and central assessment of PD-L1 using validated 22C3 assay

  2. Time to next treatment (TTNT) in each of the study arms [ Time Frame: Approximately 48 months ]
  3. Overall survival (OS) in each of the study arms [ Time Frame: Approximately 48 months ]
  4. Time to second objective disease progression (PFS2) in each of the study arms [ Time Frame: Approximately 48 months ]
  5. Cell mediated immune response [ Time Frame: Approximately 24 months ]
  6. Changes in immune cell infiltration in tumor biopsies [ Time Frame: Approximately 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920617


Locations
Show Show 38 study locations
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Merck Sharp & Dohme LLC
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Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT04920617    
Other Study ID Numbers: P1605-SUR-D23
KEYNOTE-C54 ( Other Identifier: Merck Sharp & Dohme Corp. )
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmunoVaccine Technologies, Inc. (IMV Inc.):
Immunotherapy
T cell activation
DLBCL
Anti-PD-1
CAR-T ineligible
ASCT ineligible
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Pembrolizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological