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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
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: DPX-Survivac
|
EXPERIMENTAL: Arm 2: DPX-Survivac, pembrolizumab
| DRUG: DPX-Survivac
|
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 |
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