ACTRN12619000769189
Recruiting
Phase 1
A pilot study to evaluate the safety and immunogenicity of a personalised tumour neo-antigen peptide vaccine strategy in patients with completely resected non-small cell lung cancer.
niversity of Western Australia0 sites6 target enrollmentMay 23, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Western Australia
- Enrollment
- 6
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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).
Outcomes
Primary Outcomes
Not specified
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