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    Summary
    EudraCT Number:2011-001836-44
    Sponsor's Protocol Code Number:UCL/11/0119
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-001836-44
    A.3Full title of the trial
    A Phase II Trial to Assess the Activity of TroVax® (MVA-5T4) Versus Placebo in Patients with Relapsed Asymptomatic Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial to assess the activity of Trovax versus placebo in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who have relapsed but who do not have any symptoms.
    A.3.2Name or abbreviated title of the trial where available
    TRIOC: Trovax in Relapsed Ovarian Cancer
    A.4.1Sponsor's protocol code numberUCL/11/0119
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01556841
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOxford BioMedica (UK) Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTroVax
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrovax
    D.3.9.2Current sponsor codeTroVax
    D.3.9.3Other descriptive nameMVA-5T4
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit TCID50/dose tissue culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1x10^9 TCID50/ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with relapsed asymptomatic epithelial ovarian, fallopian tube or primary peritoneal cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the ovaries and/or where it is in the fallopian tube or is the main cancer in the peritoneum (the lining of the abdominal cavity in women)
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal question of the study will assess the effectiveness of TroVax® versus placebo in extending time to progression in asymptomatic relapsed ovarian cancer patients, as measured on CT or MRI scans using RECIST 1.1/irRC criteria.
    E.2.2Secondary objectives of the trial
    • To assess delayed response by measurement of repeat CT scan using immune-related response criteria (irRC)
    • Progression-free survival (interval from randomisation/registration to progression), defined as:
    o Time when clinical intervention is required or
    o Confirmed evidence of progression as measured by RECIST 1.1/irRC criteria
    o And also death from any cause
    • Time to clinical intervention (for the treatment of symptoms of progression)or time to death
    • Incidence of clinical intervention at 25 weeks
    • CA-125 blood biomarker doubling time
    • Overall survival (time between randomisation/registration and death from any cause)
    • Patient reported quality of life measured by standardised questionnaires (EORTC QLQ C-30, EORTC QLQ OV-28)

    Immunological Endpoint
    • Antibody and cellular responses against the 5T4 tumour antigen and MVA viral vector

    Safety Endpoints
    • Toxicity related to treatment with TroVax® versus Placebo
    • Incidence and nature of clinically significant abnormal l
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged ≥18 years with histologically or cytologically proven advanced epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma.
    • Stage IC1 – III or Stage IVA* (pleural effusion only) at diagnosis.
    *According to new FIGO staging effective 01/01/2014
    • Completed cytoreductive surgery during the phase of first-line therapy including removal of bulky tumour masses and adequate surgical staging including a minimum of bilateral salpingo-ophorectomy, hysterectomy and omentectomy.
    • Completed first line platinum-based chemotherapy
    OR
    Completed first line platinum-based chemotherapy and second line chemotherapy of any type with complete response to second line treatment according to RECIST 1.1
    • Have developed relapse ≥6 months after platinum-based chemotherapy (in the case of second relapse, the disease free interval should also be ≥6 months)
    • Normal CA-125 following platinum-based chemotherapy
    • Have developed asymptomatic relapse as defined by:
    1. CA125 ≥ 2xULN
    OR
    2. Low volume radiological disease* and CA125>ULN
    *Low volume radiological disease is defined as radiologically visible disease excluding intra-hepatic (parenchymal) liver or splenic metastases, ascites or pleural effusion thought to require drainage within the next 2 months.
    The following are acceptable: Subcapsular liver and splenic lesions, benign lesions or cysts, any suspicious lesions that may represent metastases have to be confirmed by further imaging to be non-metastatic.
    • Currently asymptomatic and does not require chemotherapy.
    • Subject is assumed to be clinically immunocompetent and is free of clinically apparent/active autoimmune disease (i.e. no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave’s disease, Hashimoto’s thyroiditis, multiple sclerosis, and rheumatoid arthritis). Note: subjects with type I or type II diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease (defined as recent flare within 6 months prior to registration)
    • Subject has adequate bone marrow function as defined by Haemoglobin ≥ 110 g/L, white cell count ≥ 3.0 x 109/L, Absolute Lymphocyte Count (ALC) ≥ 1.0 x 109/L, Absolute Neutrophil Count (ANC) ≥1.5 x 109/L , Platelet Count ≥ 100 x 109/L and <400 x 109/L, Monocytes <0.8 x 109/L (for patients who have undergone previous splenectomy monocyte count can be < 1.2 x 109/L)
    • Adequate end-organ function: creatinine ≤ 2x upper limit of normal, AST and/or ALT ≤ 2x upper limit of normal, Total Bilirubin ≤ 1.5x upper limit normal
    • ECOG performance status 0-1
    • Life expectancy ≥6 months and willing to be available to attend clinic visits for treatment and for follow-up
    • Ability to give written informed consent
    • To be treated no later than 14 days from registration
    E.4Principal exclusion criteria
    • Carcino-sarcoma/MMMT
    • Cancer related symptoms, or disease recurrence requiring immediate treatment
    • CT scan showing bulky disease requiring chemotherapy, as judged by the investigator
    • Patients with low volume radiological disease in any of the following sites at trial entry:
    - Accumulating ascites thought to require drainage within the next 2 months
    - Pleural effusion thought to require drainage within the next 2 months
    - Intraparenchymal Liver and/or splenic metastases
    • Major surgery, radiotherapy, immunotherapy, hormone therapy or chemotherapy completed < 4 weeks prior to registration
    • Patients who are deemed as being immunosuppressed, receiving > 4 weeks parenteral or oral steroids, (nasal sprays and inhalers are permitted), or receiving immunosuppressive therapy following transplant
    • Chronic (≥ 6 months) oral corticosteroid use except when prescribed as replacement therapy in the case of adrenal insufficiency. If previously used for ≥6 months then must have discontinued ≥3 months prior to registration
    • “Currently active” second malignancy, other than non-melanoma skin cancer. Subjects are not considered to have a "currently active” malignancy if they have completed chemotherapy, surgery, radiotherapy ≥3 years previously and have no known evidence of residual or recurrent disease
    • Concomitant use of complementary medicines/botanicals. Supplements and conventional multivitamins are acceptable.
    • Evidence of significant clinical disorder or laboratory finding which in the opinion of the investigator makes it undesirable for the patient to participate in the trial. No participant should have a serious or uncontrolled intercurrent infection (including those positive for HIV, hepatitis B or C)
    • Psychiatric illnesses/social situations that limit compliance with protocol requirements
    • Allergy to egg proteins or history of allergic response to vaccinia vaccines
    • Prior exposure to TroVax®
    • Cerebral metastases (known from previous investigations or clinically detectable, surgically resected)
    • Patients on active treatment as part of another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is protocol-defined progression (including deaths from ovarian cancer) at 25 weeks and subsequently at 49 weeks if appropriate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 25 weeks and also at 49 weeks
    E.5.2Secondary end point(s)
    1. Assess immune-related response criteria (irRC)
    2. Progression-free survival, defined as:
    o Time when clinical intervention is required or
    o Confirmed evidence of progression as determined by RECIST 1.1 criteria and irRC 8 weeks later
    o And also death from any cause
    3. Time to clinical intervention (for the treatment of symptoms indicative of progression)or death
    4. Incidence of clinical intervention at 25 weeks
    5. CA-125 doubling time
    6. Overall survival (time between randomisation/registration and death from any cause)
    7. Patient reported outcome and health-related quality of life measured by standardised questionnaires (EORTC QLQ C-30, EORTC QLQ OV-28)
    Immunological Endpoint
    8. Antibody and cellular responses against the 5T4 tumour antigen and MVA viral vector
    Safety Endpoints
    9.Toxicity (Incidence, nature, severity, relatedness and seriousness of treatment-emergent adverse events)
    10.Incidence and nature of clinically significant abnormal laboratory test results
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At progression, assessed up to 2 years from randomisation/registration
    2. Time from rand/reg to progression or clinical intervention is required, assessed up to 2 years from rand/reg
    3. Time to clinical intervention or death, assessed up to 4 years from rand/reg
    4. Incidence at 25 weeks
    5. Time at which CA-125 value has doubled, assessed up to 2 years from rand/reg
    6. Death, assessed up to 4 years from rand/reg
    7. Quality of life assessed at multi-timepoints up to 2 years from rand/reg
    Immunological Endpoint
    8. Immunology responses, assessed at various timepoints during trial treatment (up to 49 weeks from rand/reg)
    Safety Endpoints
    9. Toxicity assessed up to 4 years from rand/reg
    10. Laboratory results assessed up to week 49
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be one year after the last patient completes active treatment at which point the ‘declaration of end of trial’ form will be submitted to participating regulatory authorities and ethical committees.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Once the patients have completed treatment of their TroVax trial they will be managed clinically in the same way as if they had not taken part in the trial. No further Trovax will be given. Further treatment options will be at the discretion of the patient's clinician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-19
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