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    Summary
    EudraCT Number:2019-004953-96
    Sponsor's Protocol Code Number:JTX-4014-202
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-22
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-004953-96
    A.3Full title of the trial
    Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination with Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects with Metastatic NSCLC After One Prior Platinum-containing Regimen
    Klinické skúšanie fázy 2 s PD-1 inhibítorom JTX-4014 použitým samostatne a v kombinácii s ICOS agonistom – vopratelimabom, v liečbe pacientov s metastatickým nemalobunkovým karcinómom pľúc selektovaných na základe biomarkerov, ktorí sú po jednej predchádzajúcej liečbe obsahujúcej platinu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of JTX-4014 Alone and in Combination with Vopratelimab in Biomarker-selected Subjects with Lung Cancer that has Spread to Other Parts of the Body After One Prior Platinum-containing Regimen

    A.4.1Sponsor's protocol code numberJTX-4014-202
    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 SponsorJounce Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJounce Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJounce Therapeutics, Inc.
    B.5.2Functional name of contact pointJounce Therapeutics
    B.5.3 Address:
    B.5.3.1Street Address780 Memorial Drive
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.6E-mailSELECT@jouncetx.com
    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 namePimivalimab
    D.3.2Product code JTX-4014
    D.3.4Pharmaceutical form Solution for injection
    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 INNPimivalimab
    D.3.9.1CAS number 2293951-22-9
    D.3.9.2Current sponsor codeJTX-4014
    D.3.9.4EV Substance CodeSUB207151
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 nameVopratelimab
    D.3.2Product code JTX-2011
    D.3.4Pharmaceutical form Solution for injection
    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 INNVOPRATELIMAB
    D.3.9.1CAS number 2039148-04-2
    D.3.9.2Current sponsor codeJTX-2011
    D.3.9.4EV Substance CodeSUB195549
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.IMP: 3
    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 nameVopratelimab
    D.3.2Product code JTX-2011
    D.3.4Pharmaceutical form Solution for injection
    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 INNVOPRATELIMAB
    D.3.9.1CAS number 2039148-04-2
    D.3.9.2Current sponsor codeJTX-2011
    D.3.9.4EV Substance CodeSUB195549
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Non Small Cell Lung Cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Lung cancer that has spread to other parts of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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
    • To demonstrate superiority of the combination of JTX-4014 with vopratelimab over JTX-4014 monotherapy in biomarker-selected subjects
    E.2.2Secondary objectives of the trial
    •To evaluate efficacy as measured by ORR, PFS, landmark PFS at 9 months, disease control rate, duration of response, and OS
    • To evaluate the safety and tolerability of JTX-4014 alone and in combination with vopratelimab
    • To evaluate the PK of JTX-4014 and vopratelimab
    • To assess the immunogenicity of JTX-4014 and vopratelimab
    • To evaluate association of baseline tumor RNA signature score with clinical outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures
    2. Histologically or cytologically confirmed diagnosis of NSCLC with evaluable or measurable disease according to RECIST v1.1 with at least 1 measurable lesion
    3. Confirmed tumor RNA signature (TISVopra) score ≥ 7.9
    4.Previously treated for locally advanced or metastatic NSCLC with 1
    prior systemic antineoplastic platinum-containing regimen. Regimen
    should consist of chemotherapy with or without bevacizumab.
    5. Age of ≥ 18 years
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    7. Predicted life expectancy of ≥ 3 months
    8. The following laboratory values:
    a. Hemoglobin ≥ 9.0 g/dL
    b. Platelet count ≥ 75 × 109 cells/L
    c. Absolute neutrophil count > 1.5 × 109 and < 10 × 109 cells/L
    d. Serum creatinine < 2 × the upper limit of normal (ULN)
    e. Total bilirubin ≤ ULN, unless the subject has a known diagnosis of Gilbert’s syndrome
    f. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN
    g. Serum albumin ≥ 75% of the lower limit of normal
    h. Lactate dehydrogenase ≤ 550 U/L
    9. If with medical history of the following, eligibility should be discussed with the Medical Monitor:
    a. Prior biliary tract disorders (based on Medical Dictionary for Regulatory Activities [MedDRA] system organ class of Hepatobiliary disorders and MedDRA high-level terms of Obstructive bile duct disorders, Hepatic vascular disorders, and Structural and other bile duct disorders)
    b. Portal hypertension and/or hepatic vascular disorders
    10. For women of childbearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned C1D1 and a negative urine or serum pregnancy test on C1D1. In addition, the WOCBP must be willing to complete a urine or serum pregnancy test prior to each dose of either study drug.
    11. WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration. Highly effective methods of birth control are defined as those that, alone or in combination, result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
    E.4Principal exclusion criteria
    1. Concurrent anticancer treatment or subject is expected to require any other form of antineoplastic therapy while on study, either approved or investigational
    2. Current or past participation in a study of an investigational agent or using an investigational device in the metastatic setting
    3. Chemotherapy < 28 days prior to planned C1D1
    4. Prior immunotherapy including, but not limited to PD-1 or PD-L1 inhibitor mAb at any time, including JTX-4014; therapy with any mAb that specifically binds to ICOS, including vopratelimab; or chimeric antigen receptor T cell therapy
    5.Organ transplantation, including allogenic or autologous stem cell
    transplantation
    6. Use of anticancer therapies listed below in the metastatic setting (allowed as prior treatment for localized disease):
    a. Biologic therapy
    b. Targeted therapy, with the exception of bevacizumab if administered
    in combination with a platinum-based chemotherapy regimen as first
    line treatment
    7. Positive test for any of the following EGFR gene mutations in blood or tumor: Exon 18 G719A; Exon 18 G719C; Exon 18 G719S; Exon 19 Del; Exon 20 S768I; Exon 20 T790M; Exon 20 Ins; Exon 21 L858R; Exon 21 L861Q
    8. The following toxicity history:
    a. Ongoing toxicity attributed to prior therapy that was Grade > 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
    Exceptions: Grade > 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement therapy) and are approved by the Medical Monitor
    b. History of pneumonitis or interstitial lung disease
    c. Symptomatic ascites or pleural effusion (subjects who are clinically stable for > 3 months following treatment for these conditions [including therapeutic thoraco- or paracentesis] are eligible)
    d. If with medical history of the following, eligibility should be discussed with the Medical Monitor: colitis, hepatitis, nephritis, skin reactions, or encephalitis.
    9. Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV Ig preparations; any history of anaphylaxis; prior history of human anti-human antibody response; or known allergy to any of the study drugs (including their analogues or excipients [L-histidine, mannitol, sodium chloride, or polysorbate 80])
    10. Major surgery (excluding minor procedures, e.g., placement of vascular access, gastrointestinal/biliary stent, and biopsy) < 4 weeks prior to planned C1D1
    11. Prior whole brain radiation
    12. Subjects with the following should be reviewed with the Medical Monitor prior to enrollment:
    a. Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
    b. Radiation (other than whole brain radiation) has been or will be administered < 21 days prior to planned C1D1
    13. Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis B, C, or human immunodeficiency virus (testing not required)
    14. Women who are pregnant, breastfeeding, or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study
    15. Concurrent second malignancy
    16. An active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents at a dose of ≥ 10 mg/day of prednisone equivalent. Subjects who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Subjects with hypothyroidism who are stable on hormone replacement therapy will not be excluded from the study.
    17. Medical or social condition that, in the opinion of the Investigator, might place the subject at an increased risk, adversely affect compliance, or confound safety or other clinical study data interpretation
    18. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
    E.5 End points
    E.5.1Primary end point(s)
    • Mean percent change from baseline tumor size of all measurable existing and new lesions averaged over 9 and 18 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study assessments and procedures will be performed as outlined in the Protocol Appendix 1 (Schedule of Assessments and Sampling Time Points for Cohort MC1) and Appendix 2 (Schedule of
    Assessments and Sampling Time Points for Cohorts CC1 and CC2).
    E.5.2Secondary end point(s)
    • ORR (percentage of subjects with CR + PR) according to RECIST, v1.1
    • PFS according to RECIST, v1.1
    • Landmark PFS rate at 9 months according to RECIST, v1.1
    • Disease control rate (confirmed CR + confirmed PR + unconfirmed SD) according to RECIST, v1.1
    • Duration of response in months according to RECIST, v1.1
    • OS
    • Incidence and grade of treatment-emergent adverse events (TEAEs)
    • PK properties of JTX-4014 and vopratelimab
    • Incidence of ADAs to either JTX-4014 or vopratelimab
    • Incidence of neutralizing antibody (NAb) to either JTX-4014 or vopratelimab
    • Association of baseline tumor RNA signature score with clinical outcomes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study assessments and procedures will be performed as outlined in the Protocol Appendix 1 (Schedule of Assessments and Sampling Time Points for Cohort MC1) and Appendix 2 (Schedule of
    Assessments and Sampling Time Points for Cohorts CC1 and CC2).
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belarus
    Bosnia and Herzegovina
    Bulgaria
    Croatia
    Georgia
    Hungary
    Latvia
    Moldova, Republic of
    Romania
    Russian Federation
    Serbia
    Slovakia
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 75
    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)
    Patients still benefitting from treatment after two years will be transferred to a roll-over protocol that will allow continued treatment with investigational medicinal product but with a reduced schedule of assessments. Jounce will begin drafting the roll-over protocol after the first patient enrolls in study 4014-202.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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