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    Summary
    EudraCT Number:2019-004895-21
    Sponsor's Protocol Code Number:WO42017
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-20
    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 number2019-004895-21
    A.3Full title of the trial
    A PHASE II, SAFETY, AND EFFICACY STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB AND ATEZOLIZUMAB MONOTHERAPY IN PATIENTS WITH METASTATIC AND/OR RECURRENT PD-L1−POSITIVE CERVICAL CANCER.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Tiragolumab plus Atezolizumab and Atezolizumab Monotherapy in Patients with Metastatic and/or Recurrent PD-L1−Positive Cervical Cancer.
    A.4.1Sponsor's protocol code numberWO42017
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04300647
    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 organisationGenentech Inc. c/o F. 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 nametiragolumab
    D.3.2Product code RO7092284/F03-01
    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 1918185-84-8
    D.3.9.2Current sponsor codeRO709-2284
    D.3.9.3Other descriptive nameTIRAGOLUMAB, MTIG7192A, anti-TIGIT, aTIGIT, PRO400402, 4.1D3
    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 number60
    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 TECENTRIQ®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameATEZOLIZUMAB, MPDL3280A
    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 number60
    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
    Cervical cancer
    E.1.1.1Medical condition in easily understood language
    Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 efficacy of tiragolumab in combination with atezolizumab and of atezolizumab monotherapy based on the objective response rate
    • To evaluate the safety and tolerability of tiragolumab in combination with atezolizumab and of atezolizumab monotherapy.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of tiragolumab in combination with atezolizumab and of atezolizumab based on the duration of response, disease control rate, best clinical response rate, progression-free survival (PFS) and overall survival (OS) after randomization, PFS and OS rate at 6 months, and 12 months (only OS rate)
    • To characterize the pharmacokinetics of tiragolumab and atezolizumab
    • To evaluate the immune response to tiragolumab and atezolizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Life expectancy >= 12 weeks
    - Ability to comply with the study protocol
    - Eastern Cooperative Oncology Group Performance Status of 0 or 1
    - Histologically confirmed primary Stage IVB, recurrent, or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after at least 1 line of prior therapy that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
    - Measurable disease
    - Formalin-fixed, paraffin-embedded (FFPE) cervical cancer tissue specimen that is programmed death-ligand 1 (PD-L1) positive, as determined by the Ventana PD-L1 (SP263) immunohistochemistry (IHC) assay, with positivity defined as tumor and tumor-infiltrating immune cells (TIC) >=5%, as determined by a central laboratory
    - Adequate hematologic and end-organ function obtained within 14 days prior to randomization
    - Negative HIV test and hepatitis B surface antigen (HBsAg) test at screening
    - Positive hepatitis B core antibody (HBsAb) test at screening, or negative HBsAb at screening
    - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
    - Recovery from the effects of surgery, radiotherapy, or chemoradiotherapy
    - No active infection requiring systemic antibiotics
    - For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of tiragolumab and/or atezolizumab.
    E.4Principal exclusion criteria
    - FFPE cervical cancer tissue specimens that is PD-L1 negative, as determined by the PD-L1 SP263 IHC assay, with positivity defined as TIC < 5%, as determined by a central laboratory
    - More than two prior systemic lines of therapy in the metastatic/recurrent setting
    - Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of tiragolumab and/or atezolizumab
    - Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
    - Planned surgery during the study
    - Current treatment with anti-viral therapy for HBV or HCV
    - Known HIV infection
    - Substance abuse within 12 months prior to screening, in the investigator's judgment
    - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
    - Bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
    - History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death after curative treatment
    - Any central nervous system /brain metastases
    - 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 >= 1 week prior to randomization
    - Leptomeningeal disease
    - Uncontrolled or symptomatic hypercalcemia
    - Known, clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
    - Active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
    - Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
    - Active tuberculosis
    - Severe infection at the time of randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
    - Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
    - Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study
    - Prior allogeneic bone marrow transplantation or solid organ transplant
    - Any other diseases, metabolic dysfunction, physical examination finding, 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 renders the patient at high risk for treatment complications
    - Illnesses or conditions that interfere with the patient’s capacity to understand, follow, and/or comply with study procedures
    - Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
    - Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to randomization
    - Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study treatment
    - History of severe allergic anaphylactic reactions to chimeric, fully humanized, or humanized antibodies or fusion proteins
    - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tiragolumab or atezolizumab formulations.
    E.5 End points
    E.5.1Primary end point(s)
    1. Objective response rate as determined by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    2. Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 36 months
    2. Up to 30 days after the final dose of study treatment or until initiation of another anti-cancer therapy.
    E.5.2Secondary end point(s)
    1. Duration of Response as determined by the IRC according to RECIST v1.1
    2. Disease control rate as determined by the IRC according to RECIST v1.1
    3. Best clinical response rate and Duration of Response as determined by the investigator
    4. PFS after randomization
    5. PFS rate at 6 months as determined by the IRC according to RECIST v1.1
    6. OS after randomization
    7. OS rate at 6 months and 12 months
    8. Minimum serum concentration (Cmin) of tiragolumab
    9. Maximum serum concentration (Cmax) of tiragolumab
    10. Minimum serum concentration(Cmin) of atezolizumab
    11. Maximum serum concentration (Cmax) of atezolizumab
    12. Prevalence of ADAs at baseline and incidence of ADAs to tiragolumab and to atezolizumab during the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Up to 36 months
    5. At 6 months
    6. Up to 36 months
    7. At 6 and 12 months
    8-11. Day 1 of Cycle 1-4, 8, 12 and 16 and at treatment discontinuation (TD) visit
    12. Baseline (Day –28 to –1), Day 1 of Cycle 1-4, 8, 12 and 16 and at TD visit.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity and Biomarker
    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 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) Yes
    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 concerned5
    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
    Australia
    Brazil
    Canada
    Costa Rica
    France
    Italy
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Spain
    Taiwan
    Thailand
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 130
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 160
    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)
    If the Sponsor decided to terminate the study, patients who are still receiving study treatment or undergoing survival follow-up may be enrolled in an extension study. (see the Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf).
    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 Decision2020-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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