Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-002150-91
    Sponsor's Protocol Code Number:ACT16941
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-02-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-002150-91
    A.3Full title of the trial
    Phase 2 non-randomized, open-label, multi-cohort, multicenter study assessing the clinical benefit of SAR444245 (THOR-707) with or without other anticancer therapies for the treatment of adults and adolescents with relapsed or refractory B cell lymphoma (Pegasus Lymphoma 205)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of SAR444245 with or without other anticancer therapies for the treatment of adults and adolescents with relapsed or refractory B cell lymphoma (Master Protocol)
    A.4.1Sponsor's protocol code numberACT16941
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1251-5834
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis France
    B.5.2Functional name of contact pointDirection des Opérations Cliniques
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Pierre Brossolette
    B.5.3.2Town/ cityChilly-Mazarin
    B.5.3.3Post code91385
    B.5.3.4CountryFrance
    B.5.4Telephone number0800222 555
    B.5.6E-mailPublic-Registry-MA-France@sanofi.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.3.2Product code SAR444245
    D.3.4Pharmaceutical form Concentrate for 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 INNSAR444245
    D.3.9.1CAS number 2573074-47-0
    D.3.9.2Current sponsor codeSAR444245
    D.3.9.3Other descriptive nameInterleukin-2, recombinant, pegylated
    D.3.9.4EV Substance CodeSUB219171
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for 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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Classic Hodgkin Lymphoma
    Diffuse large B-cell lymphoma
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    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 10020206
    E.1.2Term Hodgkin's disease
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    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 determine the antitumor activity of SAR444245 with or without other
    anticancer therapies
    E.2.2Secondary objectives of the trial
    - To confirm the dose and to assess the safety profile of SAR444245
    when combined with or without other anticancer therapies.
    - To assess other indicators of antitumor activity.
    - To assess the plasma concentrations of SAR444245 when given with or
    without other anticancer therapies.
    - To assess the immunogenicity of SAR444245
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Substudy 01 (cohort A): A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of
    SAR444245 (THOR-707) combined with pembrolizumab for the treatment of adults and adolescents with relapsed or refractory classic Hodgkin lymphoma - 16 July 2021, version 01 - See above for objectives

    - Substudy 03 (cohort C1):
    A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) as monotherapy for the treatment of adults and adolescents with relapsed or refractory diffuse large B-cell lymphoma - 16 July 2021, version 01 - See above for objectives
    E.3Principal inclusion criteria
    - Participants must be ≥ 12 years of age, at the time of signing the informed consent
    - Disease location amenable to tumor biopsy at baseline
    - All participants must have a measurable disease
    - Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
    * to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment
    * and to refrain from donating or cryopreserving eggs for 180 days after
    discontinuing study treatment.
    - Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
    - Capable of giving signed informed consent

    For cohort A (substudy 01): Histologically or cytologically confirmed diagnosis of cHL, must have received at least two prior lines of systemic therapy for cHL, including at least one containing an anthracycline or brentuximab.

    For cohort C1 (substudy 03):
    Histologically or cytologically confirmed diagnosis of DLBCL, must have received at least two prior lines of systemic therapy for DLBCL, including at least one containing a combination of anthracycline and rituximab (or another anti-CD20 agent) with the last line of therapy a marketed CD19-directed CAR-T therapy.
    E.4Principal exclusion criteria
    - Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
    (≥ 16 years old). Lansky Scale (< 16 years old) < 50%.
    - Poor bone marrow reserve
    - Poor organ function
    - Participants with baseline SpO2 ≤92%.
    - Lymphomatous involvement of the central nervous system.
    - History of allogenic or solid organ transplant
    - Last administration of prior antitumor therapy or any investigational
    treatment within 21 days or less than 5 times the half-life, whichever is
    shorter; major surgery or local intervention within 21 days.
    - Has received prior IL-2-based anticancer treatment.
    - Comorbidity requiring corticosteroid therapy
    - Antibiotic use (excluding topical antibiotics) ≤14 days prior to first
    dose of IMP
    - Severe or unstable cardiac condition within 6 months prior to starting
    study treatment
    - Active, known, or suspected autoimmune disease that has required
    systemic treatment in the past 2 years
    - Known second malignancy either progressing or requiring active
    treatment within the last 3 years
    - Receipt of a live or live attenuated virus vaccination within 28 days of
    planned treatment start. Seasonal flu vaccines or SARS-CoV-2 vaccine
    that do not contain live virus are permitted.
    E.5 End points
    E.5.1Primary end point(s)
    Complete Response Rate for Cohort A: Complete response rate (CRR) defined as the proportion of participants who have a complete response (CR) determined by Investigator per Lugano response criteria 2014

    Objective Response Rate for Cohort C1: Objective response rate (ORR) defined as the proportion of participants who have CR or partial response (PR) determined by the investigator per Lugano response criteria 2014
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approximately 8 months after the last participant receive first dose
    E.5.2Secondary end point(s)
    1) To confirm the dose of SAR444245 when combined with or without other anticancer therapies: Incidence of Dose-limiting toxicities (DLTs) during DLT observation period
    2) To assess the safety profile of SAR444245 when combined with or without other anticancer therapies: Incidence of treatment-emergent adverse events (TEAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings
    3) To assess the safety profile of SAR444245 when combined with other anticancer therapies: Incidence of serious adverse events (SAEs) and laboratory abnormalities according to NCI CTCAE V5.0 and ASTCT consensus gradings
    4) Objective Response Rate for Cohort A: Objective response rate (ORR) defined as the proportion of participants who have CR or partial response (PR) determined by Investigator per Lugano response criteria 2014
    5) Time to Response (TTR): Time from the first administration of investigational medicinal product (IMP) to the first documented evidence of PR or CR determined by Investigator per Lugano response criteria 2014
    6) Duration of Response: Duration of response (DoR) defined as the time from first documented evidence of CR or PR until progressive
    disease (PD) determined by Investigator per Lugano response criteria 2014, or death from any cause, whichever occurs first
    7) Clinical Benefit Rate (CBR): CR or PR at any time or stable disease (SD) of at least 6 months (determined by Investigator per Lugano response criteria 2014)
    8) Progression free survival: Progression free survival (PFS) defined as the time from the date of first IMP administration to the date of the first documented disease progression determined by Investigator per Lugano response criteria 2014 or death due to any cause, whichever occurs first
    9) Complete Response Rate for Cohort C1: Complete response rate (CRR) defined as the proportion of participants who have a CR determined by Investigator per Lugano response criteria 2014
    10) CAR-T cell activation and proliferation, suppression of circulating B cells for Cohort C1: CAR-T cell activation and proliferation, suppression of circulating B cells
    11) To assess the plasma concentration of SAR444245
    12) To assess incidence of anti-drug antibodies (ADAs) against SAR444245
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) DLT Observation period for cohorts A and C1 is 21 days
    2) From first IMP dose up to 30 days (30d) after last IMP dose
    3) From first IMP dose up to 90d after last IMP dose
    4,7,9,10) Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approx. 8 months after the last participant receive first dose
    5,6,8) From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
    11) At Day 1 (D1) and D15 of Cycle 1, at D1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days), max. is up to approx. 24 months
    12) At D1 and D15 of Cycle1, at D1 of Cycle 2-4-7-10 + every 5th cycle and 30 days after last IMP administration, max. is up to approx. 24 months
    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 Yes
    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 No
    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 Information not present in EudraCT
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Argentina
    Canada
    Chile
    France
    Israel
    Italy
    Korea, Republic of
    Mexico
    Spain
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants below 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 60
    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)
    None
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 12:48:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA