None listed
Conditions
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 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.
Interventions
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
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
Sponsors
University of Western Australia
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 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. If required. Completed adjuvant platinum doublet chemotherapy as per standard oncological management 14. Adequate organ and marrow function no more than 14 days prior to registration as defined below: Haemoglobin = 90g/L WBC > 2 x 109/L absolute neutrophil count > 1.5 x 109/L platelets > 100 x 109/L total bilirubin < 1.5 x ULN ALT < 3.0 x ULN creatinine < 1.5 x ULN 15. Adequate number of accessible tumour cells from resection.
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 would limit compliance with study requirements. 5. Prior or currently active significant autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement are permitted to enroll. 6. 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. 7. Pregnant or breastfeeding. A negative serum pregnancy test is required in women of childbearing potential no more than 7 days before registration. 8. Known HIV-positive status. 9. 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). 10. 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. 11. 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. 12. Therapeutic or traumatic metal implant in the skin or muscle of eligible injection sites. 13. Prisoners or subjects who are involuntarily incarcerated. 14. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
Outcome results
None listed