Brief Title
A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma
Official Title
A Cancer Research UK (CR-UK) Phase Ib Trial to Determine the Safety, Tolerability and Immunogenicity of Extended Schedule Vaccination With MVA-EBNA1/LMP2 in Patients With Epstein Barr Virus Positive (EBV+) Nasopharyngeal Carcinoma (NPC).
Brief Summary
This clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine that
has already been studied in small number of cancer patients.
The vaccine is designed to boost a patient's immunity against a common virus. The virus is
called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly
found in nasopharyngeal cancer cells.
Detailed Description
The main aims of the clinical study are to find out more about how the immune system responds
to the vaccine, more about the potential side effects of the vaccine and the effects of
giving an additional booster vaccination on the immune system.
Approximately 18 patients with EBV positive nasopharyngeal cancer (NPC) will be recruited to
the trial. Patients will receive up to four vaccinations with the MVA-EBNA1/LMP2 vaccine. The
first three vaccines will be given at 3 weekly intervals, followed by a fourth vaccine 12
weeks later. The vaccine will be given by intradermal injection with the dose divided across
multiple injection sites on the arm, or on the thigh.
Patients will participate in the study for approximately 12 months from first vaccination and
attend hospital approximately 11 times during this period. Standard safety assessments will
be performed throughout the trial and at each clinic visit patients will be asked to provide
research blood samples. These samples will be used to monitor the effects of the vaccine on
the patient's immune system.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Immune response to three cycles of MVA-EBNA1/LMP2 vaccine
Secondary Outcome
Immune memory and recall response to MVA-EBNA1/LMP2 vaccination
Condition
Nasopharyngeal Cancer
Intervention
MVA-EBNA1/LMP2 vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
22
Start Date
March 2013
Completion Date
March 10, 2017
Primary Completion Date
March 10, 2017
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed NPC in which the presence of EBV has been confirmed in the
tumour by immunohistochemistry for viral antigens or EBV early RNA (EBER) fluorescent
in situ hybridisation (FISH).
2. Patients in remission or with current disease for whom no standard therapy is
currently appropriate or required.
3. Patients who have received primary treatment for their malignancy (radiotherapy ±
chemotherapy) and up to one additional second-line course of therapy.
4. Life expectancy of at least 6 months.
5. World Health Organisation (WHO) performance status of 0 or 1 (Appendix 1).
6. Haematological and biochemical indices within the ranges shown below. These
measurements must be performed within one week (Day -7 to Day 1) before the patient
receives their first vaccination with MVA-EBNA1/LMP2.
Laboratory Test Value required Haemoglobin (Hb) ≥10.0 g/dL, Lymphocyte count ≥0.5 x
10^9/L after ≥ 6 weeks have elapsed from completion of chemotherapy, Absolute
neutrophil count (ANC) ≥1.0 x 10^9/L, Platelet count ≥ 75 x 10^9/L, Serum bilirubin
≤1.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) AND alanine
aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤ 2.5 x ULN, Calculated
creatinine clearance ≥50 mL/min (uncorrected value)
7. 18 years or over.
8. Written (signed and dated) informed consent and be capable of co-operating with
treatment and follow-up.
Exclusion criteria
1. Radiotherapy, chemotherapy, endocrine therapy, immunotherapy or investigational
medicinal products within 6 weeks prior to trial entry.
2. Patients who, in the opinion of the investigator and multidisciplinary team managing
the patient, may require another oncological treatment within 14 weeks of the first
vaccination.
3. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia
or Grade 1 toxicities, which in the opinion of the Investigator and the Sponsor should
not exclude the patient.
4. Current active auto-immune disease requiring therapy.
5. Current active eczema requiring therapy.
6. Allergy to eggs or egg products.
7. History of anaphylaxis or severe allergy to previous vaccinations or medications.
Patients with a documented history of allergy to gentamicin should be discussed with
the Sponsor prior to trial entry.
8. Previous splenectomy or splenic radiation, or with known splenic dysfunction.
9. Receiving current immunosuppressive medication including systemic use of
corticosteroids. Prophylactic use of inhaled steroids is permitted.
10. Ability to become pregnant (or already pregnant or lactating). However, those female
patients who have a negative serum or urine pregnancy test before enrolment and agree
to use two highly effective forms of contraception (oral, injected or implanted
hormonal contraception and condom, have a intra-uterine device and condom, diaphragm
with spermicidal gel and condom) during the trial and for six months afterwards are
considered eligible.
11. Male patients with partners of child-bearing potential (unless they agree to take
measures not to father children by using one form of highly effective contraception
[condom plus spermicide] during the trial and for six months afterwards). Men with
pregnant or lactating partners should be advised to use barrier method contraception
(for example, condom plus spermicidal gel) to prevent exposure to the foetus or
neonate.
12. Major thoracic or abdominal surgery from which the patient has not yet recovered.
13. At high medical risk because of non-malignant systemic disease including active
uncontrolled infection.
14. Known to be serologically positive for hepatitis B, hepatitis C or human
immunodeficiency virus (HIV).
15. History of Unstable Angina Pectoris or Myocardial Infarction up to 6 Months prior to
trial entry.
16. Any other condition which in the Investigator"s opinion would not make the patient a
good candidate for the clinical trial.
17. Is a participant or plans to participate in another interventional clinical trial,
whilst taking part in this Phase Ib study of MVA-EBNA1/LMP2. Participation in an
observational trial would be acceptable.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01800071
Organization ID
CRUKD/13/001
Responsible Party
Sponsor
Study Sponsor
Cancer Research UK
Study Sponsor
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Verification Date
July 2018