Data

ATTAC (Antigen-targeted therapy against cancer)

University of Western Australia

Dataset description

Dataset includes: demographic data, diagnostic data, and safety data for a pilot study of 6 participants with early stage non small cell lung cancer (NSCLC) to evaluate the safety of a personalised tumour neo-antigen peptide vaccine strategy. The personalised neo-antigen peptide vaccine will comprise of 5 to 10 candidate tumour neo-antigens identified by genome sequencing.
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Source Study

Trial acronym

ATTAC (Antigen-targeted therapy against cancer)

Trial ID

ACTRN12619000769189

Purpose

Treatment

Phase

Phase 1

Funding

Government body,NHMRC

Scientific enquiries

Dr Linda Ye

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 early stage 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 ....
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Key Inclusion Criteria

1. Pathologically established diagnosis of NSCLC 2. Localised disease amenable to complete surgical resection 3. > 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status =1. 5. Life expectancy of >24 weeks 6. Patients who may require adjuvant chemotherapy are eligible 7. History of prior malignancy is eligible if the following criteria are met for a cancersurvivor: 7.1. has undergone potentially curative therapy for all prior malignancies, 7.2. has been considered diseas ....
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Key Exclusion Criteria

1. Received chemotherapy, radiotherapy, or biologic therapy or other investigational therapeutic agent(s) within the last 21 days 2. Ongoing adverse effects from chemotherapy that have not resolved to = grade 1 (except haemoglobin= 90g/L is allowed) 3. Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, urticaria, or respiratory difficulty. 4. Uncontrolled significant intercurrent illness of major organ systems, or has psychiatric illness/social situation that ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    6

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Lung Cancer

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

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 ....
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Comparison

Control group Uncontrolled

No control group

Outcomes

Outcome: To evaluate the safety of the peptide vaccine strategy as assessed using CTCAE version 5.
Timepoint: From the time of the first dose of vaccination throughout the study follow-up period (52 weeks)

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au