REALISTIC: A Phase I, Dose Escalation Trial Of Recombinant Listeria Monocytogenes (Lm)-Based Vaccine Encoding Human Papilloma Virus Genotype 16 Target Antigens (ADXS11-001) In Patients With HPV-16 +ve Oropharyngeal Carcinoma
- Histologically confirmed HPV-16 +ve, p16 +ve OPSCC.
- Patients in remission from disease, i.e. complete response (CR) or unconfirmed
complete response (CRu) in the case of non-surgical treatment or complete macroscopic
resection of tumour and associated cervical lymph nodes in patients undergoing
- Completion of standard therapy for malignancy at least 6 weeks before trial entry.
- A positive result following anergy testing.
- Written informed consent and the ability of the patient to co-operate with treatment
and follow up must be ensured and documented.
- Age greater than 18 years.
- World Health Organisation (WHO) performance status of 0 or 1.
- Life expectancy of at least 12 months.
- Haematological and biochemical indices (these measurements must be performed within 8
days prior to the patient going on study):
Haemoglobin (Hb) > 10.0 g/dl Neutrophils ≥ 1.5 x 10e9/L Platelets (Plts) ≥ 100 x 10e9/L
- Baseline liver function tests:
Serum bilirubin ≤ 1.5 x upper normal limit Serum alkaline phosphatase, alanine
amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 1.5 x ULN.
- Baseline renal function test:
Calculated creatinine clearance > 50ml/min (uncorrected value) or isotope clearance
measurement > 50ml/min.
- Female patients of child-bearing potential are eligible, provided they have a
negative serum pregnancy test prior to enrolment and agree to use appropriate
medically approved contraception during the study up to six months after the last
vaccination Male patients must agree to use appropriate medically approved
contraception during the study up to six months after the last vaccination.
- Receiving, or having received, chemotherapy or radiotherapy within 6 weeks of trial
- Having undergone surgery +/- PORT within 6 weeks of trial therapy
- A negative result following anergy testing.
- Known chronic active infection with Hepatitis B, Hepatitis C or Human
Immunodeficiency Virus (HIV).
- Current active autoimmune disease.
- Current active skin diseases requiring therapy (psoriasis, eczema etc).
- Ongoing active infection.
- History of anaphylaxis or severe allergy to vaccination.
- Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic
stem cell transplant.
- Patients who have had a splenectomy or splenic irradiation, or with known splenic
- Receiving current immunosuppressive medication, including corticosteroids within 4
weeks of the first dose.
- Pregnant and lactating women.
- Ongoing toxic manifestations of previous treatment.
- Major thoracic and/or abdominal surgery in the preceding four weeks from which the
patient has not yet recovered.
- Patients with any other condition which in the Investigator‟s opinion would not make
the patient a good candidate for the clinical trial.
- Concurrent congestive heart failure or prior history of class III/ IV cardiac disease