Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04920617