Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05807035




Registration number
NCT05807035
Ethics application status
Date submitted
28/03/2023
Date registered
10/04/2023
Date last updated
27/03/2024

Titles & IDs
Public title
Autologous Tumour Vaccine Trial
Scientific title
A Phase I Trial of Autologous Tumour Vaccine for Advanced Solid Cancers
Secondary ID [1] 0 0
CAN001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Radvax

Experimental: Radvax - This is a single arm study where all participants will get active Radvax autologous tumour vaccine weekly for 4 weeks and then monthly thereafter


Other interventions: Radvax
Vaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of grade 3 or 4 adverse effects
Timepoint [1] 0 0
Interval from time of vaccination to 7 days post vaccination
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
From date of randomization to date of death from any cause, assessed up to 60 months
Secondary outcome [3] 0 0
Response rate by RECIST version 1.1
Timepoint [3] 0 0
From date of randomization, assessed each 6 months up to 60 months

Eligibility
Key inclusion criteria
- Subjects must have histologically or cytologically confirmed advanced solid cancers or
hematological cancers (lymphomas only)

- Subjects must have received at least one prior therapy for this disease, with the
exception that subjects for whom no standard therapy options exist or who decline
standard therapies can be considered for inclusion after discussions with the
investigator team.

- Performance status = 2 (ECOG performance status)

- Subjects or their parents if a child must have the ability to understand and the
willingness to sign a written informed consent document.

- If no suitable cancer tissue is already available to make the vaccine, to be enrolled
in the trial participants must be willing to undergo surgery and/or fresh tumour
biopsy to obtain tissue to allow the preparation of the vaccine and their primary care
team needs to have agreed to perform these procedures for them to obtain tumour
tissue. The trial team will provide advice on appropriate tissue collection and
arrange transport and processing but are not responsible for arranging such surgery or
paying for its cost.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment toxicities resolved to = Grade 2 according to NCI CTCAE Version 4.0,
unless these are considered by the investigator team to not be life threatening, e.g.
alopecia, neuropathy.

- Subjects receiving any other investigational agents within the preceding 4 weeks.

- Subjects with untreated brain metastases/CNS disease will be excluded from this
clinical trial because of their poor prognosis and because they often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events. Those who have controlled brain metastases will be allowed
to participate.

- Pregnant women because of the unknown risk of adverse events in the foetus secondary
to treatment of the mother with ATV.

- Any potential participant where suitable cancer tissue is not available for
preparation of the vaccine

- Any condition that the Investigator deems may make a potential participant unsuitable
for entry into the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
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
10/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/02/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
ARASMI - Adelaide
Recruitment postcode(s) [1] 0 0
5046 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Respiratory and Sleep Medicine Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Phase 1 trial to evaluate the feasibility of preparation, safety, tolerability and response
to a personalised autologous tumour vaccine (ATV) formulated with Advax adjuvant when
administered to patients with advanced solid cancers either as monotherapy or in combination
with other standard of care agents
Trial website
https://clinicaltrials.gov/ct2/show/NCT05807035
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dimitar Sajkov, MBBS/PhD
Address 0 0
ARASMI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharen Pringle, GradCert
Address 0 0
Country 0 0
Phone 0 0
0437033400
Fax 0 0
Email 0 0
office@arasmi.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05807035