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

PHASE2RECRUITING

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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. 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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-06-18

Primary completion: 2024-10-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT04920617

Intervention or treatment

DRUG: DPX-Survivac

DRUG: Pembrolizumab

DRUG: CPA

Conditions

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

Image related to Relapsed Diffuse Large B-cell Lymphoma

Condition: Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
DRUG: DPX-Survivac and other drugs
Adelaide, South Australia, Australia and more
Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Epworth Freemasons Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Westmead Hospital
Westmead, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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
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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Objective response rate (ORR) in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms	Not Specified	Approximately 24 months
Duration of response (DOR) in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Time to response in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Progression-Free Survival in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 48 months
Disease control rate (DCR) in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Complete response (CR) rate in each of the study arms	Centrally evaluated using Lugano (2014)	Approximately 24 months
Changes in Patient Reported Outcomes using the FACT-Lym Assessment	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).	Approximately 24 months
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment	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.	Approximately 24 months

Frequently Asked Questions

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References

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