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    Summary
    EudraCT Number:2022-001157-23
    Sponsor's Protocol Code Number:GO44096
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-15
    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 ConcernedGreece - EOF
    A.2EudraCT number2022-001157-23
    A.3Full title of the trial
    A PHASE II, SINGLE-ARM, OPEN-LABEL STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS OF THE INTRAVENOUS FIXED-DOSE COMBINATION (IV FDC) OF TIRAGOLUMAB AND ATEZOLIZUMAB IN PARTICIPANTS WITH LOCALLY ADVANCED, RECURRENT OR METASTATIC SOLID TUMORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed dose Combination (IV FDC) Of
    Tiragolumab and Atezolizumab in Participants with Locally Advanced, Recurrent or Metastatic Solid Tumors
    A.4.1Sponsor's protocol code numberGO44096
    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.rochegentechtrials@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 nameTIRAGOLUMAB+ATEZOLIZUMAB FDC
    D.3.2Product code RO 753-8483/F01
    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 INNTiragolumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRO7092284
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB197861
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAtezolizumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameTecentriq
    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 number80
    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 typeFixed-Dose Combination Product
    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
    Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Solid Tumors are an abnormal mass of tissue that usually does not contain cysts or liquid areas.
    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 LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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
    • To evaluate the safety and tolerability of tiragolumab and atezolizumab intravenous (IV) fixed-dose combination (FDC)
    E.2.2Secondary objectives of the trial
    • To characterize the pharmacokinetics of tiragolumab and atezolizumab following administration of IV FDC
    • To evaluate the immune response to tiragolumab and atezolizumab following IV FDC administration by measuring anti-tiragolumab and anti-atezolizumab antibodies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=18 years at the time of signing Informed Consent Form
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    • Life expectancy >=12 weeks
    • Adequate hematologic and end organ function
    • Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia
    • Negative HIV test at screening
    • Negative hepatitis B surface antigen (HBsAg) test at screening
    • Positive hepatitis B surface antibody (HBsAb) test at screening, or a negative HBsAb at screening accompanied by either of the following:
    - Negative hepatitis B core antibody (total HBcAb)
    - Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test
    • Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening
    • Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test during screening
    • For female participants of childbearing potential, negative serum pregnancy test within 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
    • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
    • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo

    Cancer-Specific Inclusion Criteria:
    • Histologic documentation of locally advanced, recurrent, or metastatic malignancy for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
    • No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
    • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    • Submittal of archival tumor and/or fresh tumor tissue to the RTD central laboratory for programmed death-1 (PD-L1) evaluation prior to enrollment
    • PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) IHC assay

    Additional Inclusion Criteria for Indication-Specific Cancer:
    • Non-small cell lung cancer (NSCLC): Participants whose tumors have a known sensitizing epidermal growth factor receptor (EGFR) mutation must also have experienced disease progression (during or after treatment) or have an intolerance to treatment with an EGFR tyrosine kinase inhibitor(s). Participants with EGFR T790M mutation positive NSCLC, one of those EGFR tyrosine kinase inhibitors must have been osimertinib if approved by local regulatory authorities for treatment of EGFR T790 mutation positive NSCLC after progression on other EGFR tyrosine inhibitors
    • Gastroesophageal junction cancer (GEJ) or EAC or esophageal squamous cell carcinoma (ESCC): Participants with Type 1 GEJ tumor, defined as adenocarcinoma of the distal esophagus with the tumor center located within 1 to 5 cm above the anatomic esophagogastric junction, are eligible for the study. Participants whose tumors are HER2-positive must have experienced disease progression (during or after treatment) or have an intolerance to treatment with Her2-tarageting antibody/HER2 inhibitor(s)
    • Participants with squamous cell carcinoma of the head and neck (SCCHN) of oral cavity, oropharynx, hypopharynx, or larynx that are inoperable. Participants with SCCHN of any other primary anatomic location in the head and neck or with SCCHN of unknown primary, or participants with tumors of non-squamous histologies are not eligible
    • Participants with urinary bladder cancer with mixed histologies are required to have a dominant transitional cell pattern
    • Participants with skin melanoma only are eligible. Those participants whose tumors have a known BRAFV600E mutation must also have experienced disease progression (during or after treatment) or have an intolerance to BRAF inhibitor(s) and/or mitogen-activated protein kinase inhibitor(s). Participants must not have received any prior cancer immunotherapy for their melanoma
    • Participants with renal cell carcinoma (RCC) must have a component of clear cell histology and/or component of sarcomatoid histology and not have received any other prior cancer immunotherapy for his/her cancer
    E.4Principal exclusion criteria
    • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
    • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
    • Poorly controlled Type 2 diabetes mellitus, defined as a screening hemoglobin A1C >=8% or a fasting plasma glucose >=160 mg/dL
    • Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
    • Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
    • History of autoimmune disease
    • Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
    • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Active tuberculosis
    • Severe infections within 4 weeks prior to Day 1 of Cycle 1
    • Recent infections not meeting the above criteria for severe infections, including the following:
    - Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
    - Received oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
    - Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
    • Prior allogeneic bone marrow transplantation or prior solid organ transplantation
    • Administration of a live, attenuated vaccine within 4 weeks before Day 1 of Cycle 1 or anticipation that such a live attenuated vaccine will be required during the study
    • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    • Known hypersensitivity to CHO-cell products
    • Allergy or hypersensitivity to components of the atezolizumab and tiragolumab IV FDC formulation

    Cancer-Specific Exclusion Criteria:
    • Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation of study treatment
    • Prior treatment with immune checkpoint inhibitors (CPIs)
    • Less than 5 drug-elimination half-lives (approximately ~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
    • Less than 6 weeks between the last dose of prior immunomodulators and the proposed Day 1 of Cycle 1
    • Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
    • Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
    • Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy
    • Any immune-mediated adverse events related to prior cancer immunotherapy
    • Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
    • Patients with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
    • Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases
    • Leptomeningeal disease
    • Uncontrolled tumor-related pain
    • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    • Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1
    • Uncontrolled hypercalcemia
    • 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 screening
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 24 months
    E.5.2Secondary end point(s)
    1. Area under the concentration time curve of tiragolumab and atezolizumab at Cycle 1
    2. Maximum serum concentration (Cmax) of tiragolumab and atezolizumab at Cycle 1
    3. Minimum serum concentration (Cmin) of tiragolumab and atezolizumab at Cycle 1
    4. Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and the incidence of treatment emergent ADAs to tiragolumab during the study
    5. Prevalence of ADAs to atezolizumab at baseline and the incidence of treatment emergent ADAs to atezolizumab during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. At Cycle 1
    4-5. During the study
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    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
    Cyprus
    Taiwan
    Canada
    Croatia
    Greece
    Korea, Republic of
    Mexico
    Serbia
    Spain
    Turkey
    United States
    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
    LVLS or the date at which the last data point required for statistical analysis (i.e., participant survival analyses) or safety follow-up is received from the last participant, whichever occurs later.

    The end of the study is expected to occur 24 months after the last participant is enrolled.
    LVLS ή η ημερομηνία κατά την οποία λαμβάνεται από τον τελευταίο συμμετέχοντα το τελευταίο σημείο δεδομένων που απαιτείται για τη στατιστική ανάλυση (δηλ. αναλύσεις επιβίωσης συμμετεχόντων) ή την παρακολούθηση της ασφάλειας, όποιο συμβεί αργότερα.

    Το τέλος της μελέτης αναμένεται να επέλθει 24 μήνες μετά την ένταξη του τελευταίου συμμετέχοντος.
    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 months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-11-15. Yes
    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
    In the event that the participant is not capable of giving consent, a LAR will sign a statement of informed consent that meets the requirements of 21 CFR 50 (U.S. sites only), the ICH Guideline for Good Clinical Practice, and the IRB/EC.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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 Decision2023-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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