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    Summary
    EudraCT Number:2017-002329-39
    Sponsor's Protocol Code Number:RE06
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-02
    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 number2017-002329-39
    A.3Full title of the trial
    Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART): An international investigator-led phase III multi-arm multi-stage randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can one drug (called durvalumab) or a combination of two drugs (called durvalumab and tremelimumab) stop kidney cancer coming back?
    A.3.2Name or abbreviated title of the trial where available
    Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART)
    A.4.1Sponsor's protocol code numberRE06
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN53348826
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03288532
    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 supportKidney Cancer UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAstraZeneca LTD UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Institute of Clinical Trials & Methodology, MRC CTU at UCL, University College London
    B.5.2Functional name of contact pointFrancesca Schiavone and Ben Smith
    B.5.3 Address:
    B.5.3.1Street Address90 High Holborn
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1V 6LJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 020 76704683
    B.5.5Fax number+44 020 7670-4818
    B.5.6E-mailmrcctu.rampart@ucl.ac.uk
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    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) No
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 nameTremelimumab
    D.3.2Product code CP-675,206 (formerly), MEDI1123
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTremelimumab
    D.3.9.1CAS number 745013-59-6
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    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) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Renal Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Cancer of the kidney
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067946
    E.1.2Term Renal cell carcinoma
    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 RAMPART trial is aiming to address two research questions:

    1. Does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab delay the cancer from coming back compared with the current standard-of-care (active monitoring) in patients with kidney cancer who underwent surgery and are at intermediate or high risk of recurrence?

    2. Does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab increase life expectancy compared with current standard-of-care (active monitoring) in patients with kidney cancer who underwent surgery and are at intermediate or high risk of recurrence?
    E.2.2Secondary objectives of the trial
    There are a number of secondary research questions that the RAMPART trial is aiming to address:

    1. Does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab delay the cancer from spreading outside the kidneys?

    2. Does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab reduces the chances of dying from kidney cancer?

    3. How does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab affect the quality of life of patients?

    4. What side effects are experienced in patients undergoing treatment with either durvalumab alone or a combination of durvalumab and tremelimumab?

    5. What are patients' preferences when it comes to treatments affecting the immune system?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All patients will be approached at the time of consent for the collection of a baseline EDTA blood sample and provision of an archival FFPE tumour sample for biomarker testing for PD-1/PD-L1 marker expression. PD-L1 testing has been requested by the Food and Drug Administration as a key aspect of the trial during the initial scientific advice consultation with the regulatory agency.

    Several translational sub-studies are being considered by the by the Trial Development Group for future development; the full umbrella of translational research associated with the main study will be detailed in a separate protocol to be submitted to the Ethics Committee in a separate instance.
    E.3Principal inclusion criteria
    1.Histologically proven RCC (all cell types of RCC are eligible, except for pure oncocytoma, collecting duct, medullary and transitional cell cancer [TCC]); no evidence of residual macroscopic disease on post-operative CT scan after resection of RCC. Patients with treated bilateral synchronous RCCs are eligible.
    2.At the start of recruitment patients with Leibovich score 3-11 will be eligible for randomisation. MRC CTU will monitor accrual and stop recruiting intermediate risk patients (Leibovich Score 3-5) after three years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich Score 6 11 will continue until the accrual target is reached.
    3.Patients should have had surgery at least 28 days but no more than 91 days prior to randomisation date.
    4. Post-operative scans should be performed within 28 days prior to randomisation
    5.WHO Performance Status 0 or 1.
    6.Patient has archival FFPE pathology tissue available, and agrees to provide at least one sample (FFPE tumour block from nephrectomy, or a minimum of 10 unstained slides), as well as a baseline EDTA blood sample for future translational research
    7.Adequate normal organ and marrow function
    a.Haemoglobin ≥9.0g/dL (transfusions will be allowed within 2 weeks of randomisation in order to achieve the entry criteria).
    b.Absolute neutrophil count (ANC) ≥1.5 x 109/L (≥1500 per mm3).
    c.Platelet count ≥100 x 109 (≥100,000 per mm3).
    d.Bilirubin ≤1.5 x ULN (This will not apply to subjects with confirmed Gilbert’s syndrome (i.e., persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician).
    e.AST/ALT ≤2.5 x ULN.
    f.Calculated Creatinine Clearance level >40mL/min by Cockcroft Gault formula
    8.12-lead ECG on which QTcF must be <470 ms. In case of clinically significant ECG abnormalities, including a QTcF value ≥470 ms, two additional 12-lead ECGs should be obtained over a brief period (e.g., 30 minutes) to confirm the finding.
    9. Patient must weight ≥30Kg at the time of randomisation
    10.Subjects must be ≥ 18 years in age.
    11.Written Informed Consent obtained from the patient
    12.Both men and women enrolled in this trial must use adequate contraception during the treatment phase of the study and for 6 months afterwards. Egg donation, sperm donation and breastfeeding must be avoided.
    13. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age specific requirements apply:
    a. Women <50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinising hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilisation (bilateral oophorectomy or hysterectomy).
    b. Women ≥50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy induced menopause with last menses >1 year ago, or underwent surgical sterilisation (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

    E.4Principal exclusion criteria
    1.Previous diagnosis of RCC.
    2.Metastatic or macroscopic residual disease.
    3.Patients with a single pulmonary nodule ≥5mm diameter are not eligible unless the nodule has had a definite benign diagnosis. Patients with multiple small, less than 5 mm nodules may be eligible if nodules have been shown to be radiologically stable for at least 8 weeks.
    4.Prior anticancer treatment (other than nephrectomy) for RCC.
    5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
    a. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
    b. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
    6. History of another primary malignancy except for:
    a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
    b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    c) Adequately treated carcinoma in situ without evidence of disease.
    7. History of leptomeningeal carcinomatosis.
    8. Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow up period of an interventional study.
    9. Major surgical procedure (as defined by the Investigator) within 28 days prior to the start of treatment. Local surgery of isolated lesions for palliative intent is acceptable.
    10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
    11. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
    a. Patients with vitiligo or alopecia
    b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    c. Any chronic skin condition that does not require systemic therapy
    d. Patients without active disease in the last 5 years may be included but only after consultation with the RAMPART Trial Management Team
    e. Patients with coeliac disease controlled by diet alone
    12. A history of immunodeficiency syndrome. Please consult the MRC CTU at UCL on an individual basis if there is any uncertainty.
    13. History of allogeneic organ transplant.
    14. Uncontrolled intercurrent illness including, but not limited to:
    a. Ongoing or active infection
    b. Symptomatic congestive heart failure
    c. Uncontrolled hypertension
    d. Unstable angina pectoris
    e. Uncontrolled cardiac arrhythmia
    f. Active peptic ulcer disease or gastritis
    g. Active bleeding diatheses
    h. Psychiatric illness or social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
    15.Active infection including
    a. Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
    b. Hepatitis B (known positive HBV surface antigen (HBsAg) result)
    c. Hepatitis C
    d. Human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti HBc] and absence of HBsAg) are eligible.
    Note: Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    16. Receipt of live attenuated vaccine within 30 days prior to the start of treatment. Note: Patients, if enrolled, should not receive live vaccine while receiving investigational medicinal product and up to 30 days after the last dose of investigational medicinal product.
    17. Pregnant or breastfeeding patients.
    18. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
    19. Known allergy or hypersensitivity to durvalumab or tremelimumab, or any of their excipients.
    20. Previous investigational medicinal product assignment in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    The RAMPART trial has two co-primary outcome measures
    1. Disease Free Survival (DFS)
    2. Overall Survival (OS)

    DFS is defined as the interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases, or death from any cause, whichever occurs first.

    OS is defined as all-cause mortality, the time from randomisation to death from any cause (including RCC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Estimated timelines for interim analyses: Disease Free Survival
    C vs A and B vs A (Overwhelming Benefit) = 4.75 years
    C vs A (Lack of Benefit) = 4.75 years
    B vs A (Lack of Benefit) = 4.75 years
    B vs A (Overwhelming Benefit)= 6.25 years
    B vs A (Lack of Benefit)= 6.25 years
    B vs A (Overwhelming Benefit)= 8 years

    Estimated timelines for primary analyses
    Disease Free Survival

    Arm C vs A = 6.25 years
    Arm B vs A = 10.5 years

    Overall survival (high-risk patients only)
    Arm C vs A = 13.25 years
    Arm B vs A = 20.5 years
    E.5.2Secondary end point(s)
    1. Metastasis Free Survival (MFS) defined as the interval from randomisation to first evidence of metastases or death from RCC
    2. RCC specific survival time
    3. Quality of Life
    4. Toxicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary outcomes will be analysed and reported at an appropriate time, which may be at the same time as the analysis and reporting of the primary outcomes.

    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    Active Monitoring (current standard-of-care)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned70
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    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 trial will close when all patients have completed follow-up and all data queries have been resolved.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years20
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years20
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 1600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state1175
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 1750
    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)
    Study participants will undergo experimental treatment for a maximum of 1 year or until progression. Patients who present with disease progression will be able to access first line therapies for metastatic renal carcinoma as recommended by NICE.

    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 Decision2017-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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