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Trial registered on ANZCTR


Registration number
ACTRN12619000769189
Ethics application status
Approved
Date submitted
17/05/2019
Date registered
23/05/2019
Date last updated
23/05/2019
Date data sharing statement initially provided
23/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate the safety and efficacy of a personalised cancer vaccine in patients with completely resected early stage lung cancer
Scientific title
A pilot study to evaluate the safety and immunogenicity of a personalised tumour neo-antigen peptide vaccine strategy in patients with completely resected stage 1 or 2A non-small cell lung cancer.
Secondary ID [1] 298271 0
None
Universal Trial Number (UTN)
Trial acronym
ATTAC (Antigen-targeted therapy against cancer)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 312883 0
Condition category
Condition code
Cancer 311377 311377 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neoantigen peptide vaccine containing 5 - 10 peptides per vaccine depending on how many high affinity binding neo-antigens are predicted for each patient (ie some patients may only have 5 high affinity neo-antigens identified)
The vaccine will be administered 2 weekly for 4 doses then 4 weekly for 4 doses as a subcutaneous injection (fortnightly for the first 4 doses then 4 weekly for the next 4 doses)

Patients are provided with treatment schedule and will be reviewed by clinician prior to each dose for safety monitoring. CRFs will be completed for each visit.

Each dose will include 500mcg - 1000mcg of synthetic peptide (100mcg per peptide) in 0.5mL of Montanide as adjuvant by subcutaneous administration
Intervention code [1] 314515 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320107 0
To evaluate the safety of the peptide vaccine strategy as assessed using CTCAE version 5.
Timepoint [1] 320107 0
From the time of the first dose of vaccination throughout the study follow-up period (52 weeks)
Secondary outcome [1] 370553 0
To evaluate the immunogenicity of the personalised tumour neo-antigen peptide vaccination by IFN-gamma ELISPOT analysis.
Timepoint [1] 370553 0
At baseline and weeks 5, 7, 11, 15, 19, 23, 35 and 52

Eligibility
Key inclusion criteria
Screening
1. Pathologically established diagnosis of NSCLC.
2. Stage 1 or 2A NSCLC
3. Not expected to receive adjuvant chemotherapy or radiotherapy for NSCLC post-surgery.
4. Greater than or equal to 18 years of age
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. Life expectancy of greater than or equal to 24 weeks.
7. History of prior malignancy is eligible if the following criteria are met for a cancer survivor:
7.1. has undergone potentially curative therapy for all prior malignancies,
7.2. has been considered disease free for at least 2 years
8. Women of reproductive potential must agree to use adequate contraception (two barrier methods or barrier method plus hormonal method of birth control; abstinence) prior to study entry and for the duration of study participation.
9. Males who are sexually active with women of reproductive potential must agree to use adequate contraception (two barrier methods or abstinence) prior to study entry and for the duration of study participation.
10. Able to provide written informed consent.
11. Must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.

Pre-Registration
12. Complete resection with margins negative for disease.
13. Adequate organ and marrow function no more than 14 days prior to registration as defined below:

Haemoglobin greater than or equal to 90g/L
WBC greater than or equal to 2 x 109/L
absolute neutrophil count greater than or equal to 1.5 x 109/L
platelets greater than or equal to 100 x 109/L
total bilirubin less than 1.5 x ULN
ALT less than 3.0 x ULN
creatinine less than 1.5 x ULN

14. Adequate number of accessible tumour cells from resection.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

1. NSCLC is upstaged to pathologic stage greater than or equal to 2B after surgery.
2. Participants who will have adjuvant treatment for NSCLC post-surgery.
3. Received chemotherapy, radiotherapy, or biologic therapy or other investigational therapeutic agent(s) within the last 30 days
4. Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, urticaria, or respiratory difficulty.
5. Uncontrolled significant intercurrent illness of major organ systems, or has psychiatric illness/social situation that would limit compliance with study requirements.
6. Prior or currently active significant autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement are permitted to enroll.
7. Subjects with a condition requiring systemic corticosteroids or other immunosuppressive medications within 14 days of study treatment. Inhaled steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease.
8. Pregnant or breastfeeding. A negative serum pregnancy test is required in women of childbearing potential no more than 7 days before registration.
9. Known HIV-positive status.
10. Any positive test result for Hepatitis B virus or hepatitis C virus indicating the presence of virus, e.g. Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
11. Known medical condition that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
12. Subjects in whom the ability to observe possible local reactions at the eligible injection sites is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
13. Therapeutic or traumatic metal implant in the skin or muscle of eligible injection sites.
14. Prisoners or subjects who are involuntarily incarcerated.
15. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302814 0
Government body
Name [1] 302814 0
NHMRC
Address [1] 302814 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [1] 302814 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 302765 0
None
Name [1] 302765 0
Address [1] 302765 0
Country [1] 302765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303397 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 303397 0

2nd Floor A Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Ethics committee country [1] 303397 0
Australia
Date submitted for ethics approval [1] 303397 0
02/01/2018
Approval date [1] 303397 0
21/02/2018
Ethics approval number [1] 303397 0

Summary
Brief summary
This is a pilot study to evaluate the safety of a personalized tumour neo-antigen peptide vaccine strategy in non-small cell lung cancer (NSCLC).

Who is it for?

You may be eligible for this study if you are an adult who has been diagnosed with stage 1 or 2A non-small cell lung cancer and is planned for surgery.

Study details

All participants in this study will be required to attend the Sir Charles Gardner Hospital to receive a vaccine fortnightly for the first 4 doses (8 weeks), and then 4 weekly for another 4 doses (16 weeks). You will monitored with blood tests before each dose.

This research project hopes to discover a new and effective treatment for patients with non-small cell lung cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93534 0
Prof Bruce Robinson
Address 93534 0
UWA School of Medicine and Pharmacology,
Level 5, Harry Perkins Research Building,
QEII Medical Centre, Nedlands, Perth, WA, 6009
Country 93534 0
Australia
Phone 93534 0
+61 8 6151 0923
Fax 93534 0
Email 93534 0
bruce.robinson@uwa.edu.au
Contact person for public queries
Name 93535 0
Dr Linda Ye
Address 93535 0
Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Ave Nedlands, WA, 6009
Country 93535 0
Australia
Phone 93535 0
+61 8 6457 3333
Fax 93535 0
Email 93535 0
yang.ye@health.wa.gov.au
Contact person for scientific queries
Name 93536 0
Dr Linda Ye
Address 93536 0
Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Ave Nedlands, WA, 6009
Country 93536 0
Australia
Phone 93536 0
+61 8 6457 3333
Fax 93536 0
Email 93536 0
yang.ye@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results