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Nasopharyngeal CancerPhase 1NCT01800071

A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma

A Phase 1 study testing MVA-EBNA1/LMP2 vaccine in people with Nasopharyngeal Cancer and Epstein Barr Virus Infections, run by Cancer Research UK at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MVA-EBNA1/LMP2 vaccine
Type of treatment
Vaccines
How many people
22 participants
Where
5 sitesUnited Kingdom
Study dates
Mar 2013to 10 Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Patients in remission or with current disease for whom no standard therapy is currently appropriate or required.
  • Patients who have received primary treatment for their malignancy (radiotherapy ± chemotherapy) and up to one additional second-line course of therapy.
  • Life expectancy of at least 6 months.
  • World Health Organisation (WHO) performance status of 0 or 1 (Appendix 1).
  • 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.
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  • 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)
  • 18 years or over.
  • Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.

Who cannot join

  • Radiotherapy, chemotherapy, endocrine therapy, immunotherapy or investigational medicinal products within 6 weeks prior to trial entry.
  • 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.
  • 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.
  • Current active auto-immune disease requiring therapy.
  • Current active eczema requiring therapy.
  • Allergy to eggs or egg products.
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  • 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.
  • Previous splenectomy or splenic radiation, or with known splenic dysfunction.
  • Receiving current immunosuppressive medication including systemic use of corticosteroids. Prophylactic use of inhaled steroids is permitted.
  • 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.
  • 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.
  • 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).
  • History of Unstable Angina Pectoris or Myocardial Infarction up to 6 Months prior to trial entry.
  • Any other condition which in the Investigator"s opinion would not make the patient a good candidate for the clinical trial.
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • University of Birmingham

    Edgbaston, Birmingham, B15 2TT

  • Royal Marsden Hospital

    Fulham Road, London, SW3 6JJ

  • The Beatson West of Scotland Cancer

    Glasgow, G12 0YN

  • The Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

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).

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.

Read the 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.

Being tested
MVA-EBNA1/LMP2 vaccine
Keywords
Nasopharyngeal cancer, Epstein Barr Virus Infections, Vaccination
Medical subject headings
Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA-EBNA1/LMP2 vaccineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response to three cycles of MVA-EBNA1/LMP2 vaccine

    To be determined by ex vivo ELIspot assays quantifying EBV EBNA1 and LMP2-specific effectors in samples before vaccination, during the three cycle vaccine course and within 4 weeks after the third vaccine cycle.

    Measured: pre-vaccination to 4 weeks post third vaccine

  2. Occurrence of adverse events defined according to NCI CTCAE version 4.02

    Measured: 12 months

Secondary outcomes (3)

  1. Immune memory and recall response to MVA-EBNA1/LMP2 vaccination

    To be determined by ex vivo ELIspot assays quantifying EBV EBNA1 and LMP2-specific effectors in samples before and within 4 weeks after the first and fourth vaccine cycles

    Measured: pre and post vaccines one and four.

  2. Measurement of EBV genome levels in plasma before, during and after vaccination

    Measured: pre- vaccination to 12 months post vaccination

  3. Tumour response as determined by Immune-Related Response Criteria (irRC)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completion10 Mar 2017
  4. Study completion10 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800071
Sponsor's protocol ID
CRUKD/13/001
Status last verified
Jul 2018
First submitted
25 Feb 2013
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-EBNA1/LMP2 vaccine in people with Nasopharyngeal Cancer and Epstein Barr Virus Infections, run by Cancer Research UK at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune response to three cycles of MVA-EBNA1/LMP2 vaccine (time frame: pre-vaccination to 4 weeks post third vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01800071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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