ATTAC (Antigen-targeted therapy against cancer)
ACTRN12619000769189
Treatment
Phase 1
Government body,NHMRC
Dr Linda Ye
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 .... Read more
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 .... Read more
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 .... Read more
No
Sample Size 6
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Lung Cancer
Condition code Cancer
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 .... Read more
Control group Uncontrolled
No control group
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)