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    Summary
    EudraCT Number:2021-001415-90
    Sponsor's Protocol Code Number:MO42720
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-13
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-001415-90
    A.3Full title of the trial
    INTERVENTIONAL PLATFORM STUDY
    INVESTIGATING THE IMPACT OF DIGITAL HEALTH
    SOLUTIONS ON HEALTH OUTCOMES AND
    HEALTH-CARE RESOURCE UTILIZATION IN
    PARTICIPANTS RECEIVING SYSTEMIC
    TREATMENT IN CLINICAL PRACTICE (ORIGAMA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interventional Platform Study Investigating the Impact of Digital Health Solutions on Health Outcomes and Health-Care Resource Utilization in Participants Receiving Systemic Treatment in Clinical Practice (ORIGAMA)
    A.3.2Name or abbreviated title of the trial where available
    ORIGAMA
    A.4.1Sponsor's protocol code numberMO42720
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05694013
    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 SponsorF. Hoffmann La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche, Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameATEZOLIZUMAB SC
    D.3.2Product code RO5541267
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAtezolizumab
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameAnti-PDL1
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Cohort A:
    ●Metastatic non-small cell lung carcinoma (mNSCLC)
    ●Extensive-stage small-cell lung carcinoma (ES-SCLC)
    ●Advanced or unresectable hepatocellular carcinoma (HCC)
    Cohort B: Resected Stage IIB, IIIA, IIIB(T3-N2) non-small cell lung
    carcinoma (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Cohort A: People with one of two types of advance lung cancer or one
    type of liver cancer
    Cohort B: People with one type of resected early/loco regional lung cancer
    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 LLT
    E.1.2Classification code 10025064
    E.1.2Term Lung carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036706
    E.1.2Term Primary liver cancer non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cohort A
    To demonstrate superiority of the Roche digital patient monitoring (DPM) atezolizumab Module on symptom interference, when used on top of SOC

    Cohort B
    To evaluate the feasibility of combining the Roche DPM atezolizumab subcutaneous (SC) Module and atezolizumab SC administered at the patient's home
    E.2.2Secondary objectives of the trial
    Cohort A
    To assess the impact of the Roche DPM atezolizumab Module on number of hospitalizations and number of cumulative days hospitalized due to SAEs, unscheduled visits to the ER or clinic visits for symptom management, incidence, nature, and severity of all anti-cancer treatment associated AEs with additional analyses on Grade >= 3 AEs, SAEs, selected immune-related adverse events, WTS, interruption, modification, or discontinuation of atezolizumab regimen due to AEs, change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the EORTC IL6 GHS/QoL, in EuroQol EQ-5D-5L index-based and VAS instrument and in the mean symptom severity score from the MDASI Core Items

    To assess the safety of the Roche DPM atezolizumab Module compared with local standard of care (SOC) support
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Participants
    ●Participant is aged >= 18 years
    ●Participant has an email address, access to an internet-capable device,
    and access to an internet connection
    Cohort A
    ●Participants must have a histologically confirmed diagnosis via local
    labs
    ● Participant is systemic therapy naïve
    ● Eastern cooperative oncology group (ECOG) performance status of 0,
    1, or 2
    ● Life expectancy >= 12 weeks
    Cohort B
    Participants must confirm adequacy of their home to conduct trial
    related procedures at home
    ● Participants must have a complete resection of a histologically or
    cytologically confirmed Stage IIB-IIIB (T3-N2) non-small cell lung
    carcinoma (NSCLC)
    ● Programmed cell death-ligand 1 (PD-L1) positive as documented
    through local testing performed per manufacturer's recommendations
    and requirements of a representative tumor tissue specimen. An
    appropriate CE marked or IVDR approved test should be used for local
    testing of PD-L1.
    ● Participants must have completed adjuvant chemotherapy at least 4
    weeks and up to 12 weeks prior to randomization and must be
    adequately recovered from chemotherapy treatment
    ● ECOG Performance Status of 0 or 1
    ● Adequate hematologic and end-organ function
    ● For participants receiving therapeutic anticoagulation: stable
    anticoagulant regimen
    ● Negative human immunodeficiency virus (HIV) test at screening, with
    the following exception: participants with a positive HIV test at
    screening are eligible provided they are stable on anti-retroviral therapy,
    have a CD4 count >= 200/μL, and have an undetectable viral load
    ● Negative hepatitis B surface antigen (HBsAg) test at screening
    ● Negative hepatitis B surface antibody (HBsAb) or positive HBsAb test
    at screening
    ● Negative hepatitis C virus (HCV) antibody test or positive HCV
    antibody test followed by a negative HCV ribonucleic acid (RNA) test at
    screening
    ● For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab
    E.4Principal exclusion criteria
    All Participants
    ●Participants with any physical or cognitive condition that, according to
    clinical judgment, would prevent the participant from using the DHS
    ●Participants not proficient with any of the available DHS language translations or with psychiatric/neurologic disorders or any condition
    that may impact the participant's ability to use the DPM solution
    ●Participants currently enrolled in another clinical study, unless it is an
    observational (non-interventional) clinical study or the follow-up period
    of an interventional study
    Cohort A
    ●Concomitant anti-cancer therapy at the time of starting atezolizumab
    (IV) regimen on the index date which is not part of a locally approved
    combination therapy with atezolizumab as per summary of product
    characteristics (SmPC) or local regulatory documents
    ●Participants not receiving atezolizumab, but an atezolizumab biosimilar
    or noncomparable biologic
    ●Participants currently using another DPM, or electronic participant
    reported outcome (ePRO) solution for symptom management and/or
    reporting
    Cohort B
    ●Participants known to have a sensitizing mutation in the epidermal
    growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase
    (ALK) fusion oncogene
    ● History of malignancy within 5 years prior to initiation of study
    treatment, with the exception of the cancer under investigation in this
    study and malignancies with a negligible risk of metastasis or death
    (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in
    situ of the cervix, non-melanoma skin carcinoma, localized prostate
    cancer, ductal carcinoma in situ, or Stage I uterine cancer
    ●Uncontrolled tumor-related pain
    ●Uncontrolled or symptomatic hypercalcemia
    ●Active or history of autoimmune disease or immune deficiency
    ●History of idiopathic pulmonary fibrosis, organizing pneumonia druginduced
    pneumonitis, or idiopathic pneumonitis, or evidence of active
    pneumonitis on screening chest computed tomography (CT) scan
    ●Active tuberculosis
    ●Significant cardiovascular disease within 3 months prior to initiation of
    study treatment, unstable arrhythmia, or unstable angina
    ●Major surgical procedure, other than for diagnosis, within 4 weeks prior
    to initiation of study treatment, or anticipation of need for a major
    surgical procedure during the study
    ●Severe infection within 4 weeks prior to initiation of study treatment
    ●Treatment with therapeutic oral or intravenous (IV) antibiotics within 2
    weeks prior to initiation of study treatment
    ●Prior allogeneic stem cell or solid organ transplantation
    ●Any other disease, metabolic dysfunction, physical examination finding,
    or clinical laboratory finding that contraindicates the use of an
    investigational drug, may affect the interpretation of the results, or may
    render the participant at high risk from treatment complications
    ●Treatment with a live, attenuated vaccine within 4 weeks prior to
    initiation of study treatment, or anticipation of need for such a vaccine
    during atezolizumab treatment or within 5 months after the final dose of
    atezolizumab
    ●Current treatment with anti-viral therapy for hepatitis B virus (HBV)
    ●Treatment with investigational therapy within 28 days prior to initiation
    of study treatment
    ●Prior treatment with CD137 agonists or immune checkpoint blockade
    therapies, including anti- cytotoxic T-lymphocyte-associated protein 4
    (CTLA-4), anti– programmed cell death protein 1 (PD-1), and anti–
    programmed cell death-ligand 1 (PD-L1) therapeutic antibodies
    ●Treatment with systemic immunostimulatory agents and systemic
    immunosuppressive medication
    ●History of severe allergic anaphylactic reactions to chimeric or
    humanized antibodies or fusion proteins
    ●Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
    ●Pregnancy or breastfeeding, or intending to become pregnant during
    study treatment or within 5 months after the final dose of study
    treatment
    ●Known allergy or hypersensitivity to hyaluronidase, bee or vespid
    venom, or any other ingredient in the formulation of recombinant human
    hyaluronidase enzyme (rHuPH20)
    ●Pathology that could interfere with any protocol-specified outcome
    assessment
    ●Spinal cord compression not definitively treated with surgery and/or
    radiation, or previously diagnosed and treated spinal cord compression
    without evidence that disease has been clinically stable for >= 2 weeks
    prior to randomization
    ●Participants currently using another DPM or ePRO solution for symptom
    management and/or reporting
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A
    1.Mean difference in change of Week 12 value from baseline of the
    participant-reported Total Symptom Interference Score from the MD
    Anderson Symptom Inventory (MDASI) Core Items
    Cohort B
    2.At home treatment adoption at Cycle 6
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Cohort A: From baseline (Cycle 1, Day 1) to Week 12
    2.Cohort B: At Cycle 6
    E.5.2Secondary end point(s)
    Cohort A
    1.Number of hospitalizations and number of cumulative days
    hospitalized due to serious adverse events (SAEs)
    2.Unscheduled visits to the emergency room (ER) or clinic visits for
    symptom management
    3.Incidence, nature, and severity of all anti-cancer treatment associated
    adverse event (AEs) graded according to the National Cancer Institute
    Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with
    additional analyses on Grade >= 3 AEs, Serious adverse events (SAEs),
    selected immune-related adverse events, weighted toxicity score (WTS),
    interruption, modification, or discontinuation of atezolizumab regimen
    due to AEs
    4.Change from baseline in Global Health Status score/Quality of Life
    score (GHS/QoL) from the European Organisation for Research and
    Treatment of Cancer (EORTC) item library 6 (IL6) GHS/QoL
    5.Change from baseline in EuroQoL 5-Dimension, 5-Level Questionnaire
    (EQ-5D-5L) index-based and visual analogue Scale (VAS) instrument
    6.Change from baseline in the mean symptom severity score from the
    MDASI Core Items
    7.Incidence and severity of adverse events assessed as related to device
    use and adverse device effects
    Cohort B
    8. Number of hospitalizations within one day of atezolizumab SC
    administration due to SAEs
    9. Incidence, nature, and severity of all atezolizumab SC associated AEs
    graded according to the NCI-CTCAE v5.0 with additional analyses on Grade >= 3 AEs, SAEs
    E.5.2.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cohort A and B
    1-3.Up to 90 days after the participant receives the last dose of atezolizumab (IV) treatment or discontinues atezolizumab treatment (follow up telephone call).
    4-6.From baseline (Cycle 1, Day 1), Weeks 6, 12, 18, 24 and follow-up
    telephone call (90 days)
    7-9.Up to 90 days after the participant receives the last dose of atezolizumab (IV) treatment or discontinues atezolizumab treatment (follow up telephone call).
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Cohort A investigates the health outcomes in people
    prescribed a locally approved anti-cancer regimen containing atezolizumab using a Digital Health tool.
    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 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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Oman
    Switzerland
    Australia
    Austria
    Estonia
    Finland
    Germany
    Italy
    Lebanon
    Norway
    Spain
    E.8.7Trial has a data monitoring committee No
    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 study for Cohorts A and B is defined as the date at which the last data point required for statistical analysis is received from the last participant.
    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 months5
    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 months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 440
    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)
    Participants will return to the clinic for a treatment discontinuation visit ≤30 days after the
    final scheduled treatment (please refer to Appendix 1 of protocol for additional details). An earlier visit may be
    used as the treatment discontinuation visit if a local assessment of tumor response
    indicates a loss of clinical benefit.
    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 Decision2022-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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