Status:
COMPLETED
AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Cancer Research UK
Conditions:
Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This clinical study is looking at a vaccine called AST-VAC2 in adult patients with advanced non-small cell lung cancer (NSCLC). The main aim of the study: If the dose can be given safely to patients, ...
Detailed Description
This clinical study is looking at a vaccine called AST-VAC2. AST-VAC2 has been designed to potentially help the immune system attack the cancer. This is a new vaccine which looks promising in laborato...
Eligibility Criteria
Inclusion
- a) Patients with advanced NSCLC (metastatic or locally advanced), for whom there are no other suitable treatment options.-
- Able to and likely to be well enough to receive six vaccinations i.e. judged by the Investigator to not require alternate treatment for the duration of the vaccination schedule and period to end of vaccination visit.
- Has had sufficient wash out periods from previous treatments as follows:
- i) four weeks for chemotherapy ii) six weeks for investigational medicinal products (IMPs) iii) eight weeks for immunotherapy (shorter intervals may be acceptable based on half-life of treatment. Eligibility will be confirmed by the Sponsor and CI).
- Measurable disease
- Biopsiable disease is preferable however patients without biopsiable disease can still be considered for the study.
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- Confirmed HLA A\*02:01 positive genotype.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-2.
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed prior to the patient receiving the first AST-VAC2 vaccination.
- Laboratory Test and Value required
- Haemoglobin (Hb) ≥9.0 g/dL; Absolute neutrophil count (ANC) ≥1.5 x 10\^9 /L; Platelet count ≥100 x 10 \^9/L; Lymphocyte count ≥1.0 x 10\^9 /L; Bilirubin ≤1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 3.0 x ULN; Calculated creatinine clearance \> 30 mL/min
- 18 years or over at the time consent is given.
Exclusion
- Radiotherapy (except for palliative reasons) during the previous four weeks before treatment.
- Ongoing toxic manifestations of previous treatments greater than CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
- Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial with the exception of replacement treatment. Inhaled and topical steroids are permitted. The predictable need of their use will preclude the patient from trial entry.
- Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\] or agree to sexual abstinence\*, effective from the first administration of AST-VAC2 throughout the trial and for six months afterwards are considered eligible.
- Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception \[condom plus spermicide\] or to sexual abstinence\* effective from the first administration of AST-VAC2, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
- \*Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- Evidence of any ongoing active autoimmune disease.
- Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\]), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I trial of AST-VAC2. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.
- Any vaccination given within four weeks before the first AST-VAC2 vaccination (except for COVID-19 vaccinations which are permitted at investigators discretion).
- Any planned prophylactic vaccination from trial entry until completion of the AST-VAC2 vaccinations (except for COVID-19 vaccinations which are permitted at investigators discretion).
- Any condition which might interfere with the patient's ability to generate an immune response.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03371485
Start Date
May 29 2018
End Date
August 8 2022
Last Update
August 9 2024
Active Locations (2)
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1
Queen Elizabeth Hospital
Birmingham, United Kingdom
2
Southampton General Hospital
Southampton, United Kingdom