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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04920617




Registration number
NCT04920617
Ethics application status
Date submitted
28/05/2021
Date registered
10/06/2021
Date last updated
7/04/2023

Titles & IDs
Public title
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Scientific 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)
Secondary ID [1] 0 0
KEYNOTE-C54
Secondary ID [2] 0 0
P1605-SUR-D23
Universal Trial Number (UTN)
Trial acronym
VITALIZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed Diffuse Large B-cell Lymphoma 0 0
Refractory Diffuse Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DPX-Survivac
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - CPA

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.

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.


Treatment: Drugs: DPX-Survivac
SC injection on D7 and D28, then every 8 weeks

Treatment: Drugs: Pembrolizumab
IV infusion every 3 weeks

Treatment: Drugs: CPA
50 mg twice daily, week on then week off
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) in each of the study arms
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [2] 0 0
Duration of response (DOR) in each of the study arms
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
Time to response in each of the study arms
Timepoint [3] 0 0
Approximately 24 months
Secondary outcome [4] 0 0
Progression-Free Survival in each of the study arms
Timepoint [4] 0 0
Approximately 48 months
Secondary outcome [5] 0 0
Disease control rate (DCR) in each of the study arms
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [6] 0 0
Complete response (CR) rate in each of the study arms
Timepoint [6] 0 0
Approximately 24 months
Secondary outcome [7] 0 0
Changes in Patient Reported Outcomes using the FACT-Lym Assessment
Timepoint [7] 0 0
Approximately 24 months
Secondary outcome [8] 0 0
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment
Timepoint [8] 0 0
Approximately 24 months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Epworth Freemasons Hospital - Melbourne
Recruitment hospital [3] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 0 0
3128 - Melbourne
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Dakota
Country [12] 0 0
Canada
State/province [12] 0 0
Saskatchewan
Country [13] 0 0
France
State/province [13] 0 0
Bobigny
Country [14] 0 0
France
State/province [14] 0 0
Nancy
Country [15] 0 0
France
State/province [15] 0 0
Nantes
Country [16] 0 0
France
State/province [16] 0 0
Nice
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Pessac
Country [19] 0 0
France
State/province [19] 0 0
Périgueux
Country [20] 0 0
France
State/province [20] 0 0
Saint-Quentin
Country [21] 0 0
Hungary
State/province [21] 0 0
Debrecen
Country [22] 0 0
Hungary
State/province [22] 0 0
Nyíregyháza
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland Province
Country [24] 0 0
New Zealand
State/province [24] 0 0
Manawatu
Country [25] 0 0
Poland
State/province [25] 0 0
Gdynia
Country [26] 0 0
Poland
State/province [26] 0 0
Legnica
Country [27] 0 0
Poland
State/province [27] 0 0
Olsztyn
Country [28] 0 0
Poland
State/province [28] 0 0
Skórzewo
Country [29] 0 0
Poland
State/province [29] 0 0
Warszawa
Country [30] 0 0
Romania
State/province [30] 0 0
Bucharest
Country [31] 0 0
Romania
State/province [31] 0 0
Cluj-Napoca
Country [32] 0 0
Serbia
State/province [32] 0 0
Belgrade
Country [33] 0 0
Serbia
State/province [33] 0 0
Kragujevac
Country [34] 0 0
Serbia
State/province [34] 0 0
Sremska Kamenica
Country [35] 0 0
Serbia
State/province [35] 0 0
Zemun
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Burgos
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04920617
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04920617