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    Summary
    EudraCT Number:2020-004606-60
    Sponsor's Protocol Code Number:BP42772
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004606-60
    A.3Full title of the trial
    A 3-ARM, RANDOMIZED, BLINDED, ACTIVE-CONTROLLED, PHASE II STUDY OF RO7121661, A PD1-TIM3 BISPECIFIC ANTIBODY AND RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, COMPARED WITH NIVOLUMAB IN PARTICIPANTS WITH ADVANCED OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE ESOPHAGUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Effects of RO7121661 and RO7247669 Compared With Nivolumab in Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
    A.4.1Sponsor's protocol code numberBP42772
    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 namePD1-TIM3
    D.3.2Product code RO7121661
    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 INNN/A
    D.3.9.2Current sponsor codeRO7121661/F01-01
    D.3.9.3Other descriptive namePD1-TIM3
    D.3.9.4EV Substance CodeSUB192832
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 namePD1-LAG3
    D.3.2Product code RO7247669
    D.3.4Pharmaceutical form Solution for injection/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 INNN/A
    D.3.9.2Current sponsor codeRO7247669/F01-01
    D.3.9.3Other descriptive namePD1-LAG3
    D.3.9.4EV Substance CodeSUB198818
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 OPDIVO®
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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.3.1Product nameOPDIVO
    D.3.2Product code RO7344269
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94
    D.3.9.2Current sponsor codeRO7344269
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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 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
    Advanced or metastatic squamous cell carcinoma of the esophagus
    E.1.1.1Medical condition in easily understood language
    Squamous cell carcinoma forms in the thin, flat cells lining the inside of the esophagus. It is most often found in the upper and middle part of the esophagus
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10015362
    E.1.2Term Esophageal cancer
    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 efficacy of RO7121661 and RO7247669 compared with nivolumab based on overall survival
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of RO7121661 and RO7247669 compared with nivolumab
    • To evaluate the efficacy of RO7121661 and RO7247669 compared with nivolumab based on objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS) and proportion of participants reporting clinically meaningful improvement in global health status/quality of life, emotional functioning, social functioning and dysphagia
    • To investigate the pharmacokinetics (PK) of RO7121661, RO7247669, and nivolumab
    • To evaluate the immune response after administration of RO7121661, RO7247669, and nivolumab
    • To assess treatment-induced pharmacodynamic (PD) changes (PD Biomarkers) in peripheral blood and tumor microenvironment
    • To assess baseline characteristics in the tumor microenvironment as predictive biomarkers of response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=18 years
    • Participants with advanced or metastatic histologically confirmed esophageal squamous-cell carcinoma (ESCC)
    • Patients who have previously received 1 line of treatment with either a fluoropyrimidine- and platinum- or a taxane- and platinum-based regimen in non-curative intention prior to randomization or patients who received treatment with a fluoropyrimidine-/taxane- and platinum-based regimen in curative intention and had recurrence within 24 weeks after the last dose of the treatment.
    • Radiologically measurable disease according to Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy
    • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
    • A life expectancy of >=12 weeks
    • Tissue samples must be provided for analysis of anti–programmed death-1 (PD-L1) tumor positivity.
    • Adequate cardiovascular function
    • AEs from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade <=1, except alopecia (any grade), vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy
    • Adequate hematological function
    • Adequate liver function
    • Adequate renal function
    • Serum albumin >=25 grams per liter (g/L),
    • For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time <=1.5*Upper limit of normal (ULN), for participants receiving therapeutic anticoagulation: stable anticoagulant regimen
    • Male and/or female participants. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) and WOCBP, who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 5 months after the final dose of study drug and have a negative pregnancy test (blood) within the 7 days prior to randomization. A male participant must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method during the treatment period and for at least 5 months after the final dose of study drug
    E.4Principal exclusion criteria
    • Pregnancy, lactation, or breastfeeding
    • Known hypersensitivity to any of the components of RO7121661, RO7247669, or nivolumab, including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
    • Patients with significant malnutrition. Patients whose nutrition has been well controlled for >=28 days prior to randomization may be enrolled
    • Evidence of complete esophageal obstruction not amenable to treatment
    • Higher risk of bleeding or fistula caused by esophageal lesions invading adjacent organs (aorta or tracheobronchial tree)
    • Symptomatic central nervous system (CNS) metastases
    • Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for >=14 days prior to randomization
    • Active or history of carcinomatous meningitis/leptomeningeal disease
    • Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization
    • Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry
    • Patients with an active second malignancy
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar/plantar fibromatosis, etc.).
    • Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
    • Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
    • Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis [TB] and typical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 28 days prior to randomization
    • Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease.
    • Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
    • 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 render the participant at high risk from treatment complications
    • Dementia or altered mental status that would prohibit informed consent
    • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (expected to occur once monthly or more frequently).
    • Active or history of autoimmune disease or immune deficiency
    • Positive human immunodeficiency virus (HIV) test at screening
    • Positive hepatitis B surface antigen (HBsAg) or positive total hepatitis B core antibody (HBcAb) test at screening
    • Positive hepatitis C virus (HCV) antibody test at screening
    • Prior cancer therapy with any immunomodulatory agents including checkpoint inhibitor (CPIs) (such as anti-PDL1/PD1, anti-CTLA-4, anti-LAG3, anti-TIM3)
    • Vaccination with live vaccines within 28 days prior to randomization, or anticipation that a live attenuated vaccine will be required during the study
    • Treatment with therapeutic oral or IV antibiotics within 14 days prior to randomization
    • Concurrent therapy with any other investigational drug (defined as treatment for which there is currently no regulatory authority approved indication) 28 days or 5 half-lives of the drug (whichever is shorter) prior to randomization
    • Treatment with immune-modulating and immune suppressive agents/medication 5 half-lives or 28 days (whichever is shorter) prior to randomization
    • Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease)
    • Radiotherapy within the last 28 days before start of study drug treatment is not allowed, with the exception of limited palliative radiotherapy
    • Prior treatment with adoptive cell therapies, such as Chimeric antigen receptor T cells (CAR-T) therapies
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From randomization to death (approximately 27 months)
    E.5.2Secondary end point(s)
    1. Frequency, and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
    2. ORR, defined as the proportion of participants with an objective response (i.e., complete response [CR] or partial response [PR]), according to RECIST v1.1
    3. DCR defined as ORR plus stable disease rate (SDR)
    4. DoR for participants with ORR, defined as the time from the first occurrence of a documented objective response to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
    5. PFS defined as the time from randomization to the first occurrence of progression as determined according to RECIST v1.1 or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first
    6. Percentage of participants reporting clinically meaningful improvement in global health status/quality of life, emotional functioning, social functioning and dysphagia as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30, defined as an improvement of at least 10 points
    7. Percentage of participants reporting clinically meaningful improvement in global health status/quality of life, emotional functioning, social functioning and dysphagia as measured by the EORTC-QLQ-IL97, defined as an improvement of at least 10 points
    8. Percentage of participants reporting clinically meaningful improvement in global health status/quality of life, emotional functioning, social functioning and dysphagia as measured by the EORTC-QLQ-OES-18, defined as an improvement of at least 10 points
    9. Serum concentrations of RO7121661
    10. Serum concentrations of RO7247669
    11. Serum concentrations of nivolumab
    12. Incidence and titer of anti-drug antibodies (ADAs) against RO7121661 during the study relative to the prevalence of ADAs at baseline
    13. Incidence and titer of ADAs against RO7247669 during the study relative to the prevalence of ADAs at baseline
    14. Incidence and titer of ADAs against nivolumab during the study relative to the prevalence of ADAs at baseline
    15. Changes from baseline in the phenotype and activation status (CD4/CD8 HLA-DR+Ki67+) of T cell subsets in the peripheral blood
    16. Changes from baseline such as CD8 T cell infiltration, proliferation (CD8+Ki67+) in the tumor microenvironment
    17. Baseline PDL1, CD8+PD1+, CD8+TIM3+, and CD8+LAG3+ expression in the tumor microenvironment
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5. Up to 27 months
    6. Day 1 of Cycles 1, 4, 7, and 10 (and then every 3 months until the completion of the first year post discontinuation)
    7. Day 1 of Cycles 1, 2, 3, 5, 6, 8 and 9
    8. Day 1 of Cycles 1, 2, 3, 4, 5, 6, 7, 8 and 9 (and then every 3 months until the completion of the first year post discontinuation)
    9-11. Days 1 and 8 of Cycle 1; Day 1 of Cycles 2, 3, 4; Days 1 and 8 of Cycle 5; and then Day 1 of subsequent cycles
    12-14. Day 1 of Cycles 1, 2, 3, 4, 5, 7 and then Day 1 of every 3 cycles
    15. Screening (Day -28 to -1) and Day 1 of Cycles 1, 2, 3, 5, 9 and then Day 1 of every 3 cycles
    16: Based on an archival sample or at Screening (Day-28 to -1) and Cycle 3 Day 1
    17. Based on an archival sample or at Screening (Day-28 to -1)
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 EEA38
    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
    Belgium
    Czechia
    Denmark
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Singapore
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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 will occur when all of the following criteria have been met:
    • The required number of deaths for the primary analysis of OS has been observed.
    • The last participant, last visit has occurred.
    The Sponsor has the right to terminate this study at any time. Further information can be found in Section 4.3 in the protocol.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 255
    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)
    Currently, the Sponsor does not have any plans to provide RO7121661, RO7247669, nivolumab, or any other study treatments or interventions to the participants after the end of the study or when participants discontinue or have been withdrawn from the study. The Sponsor will evaluate whether to continue providing RO7121661 and/or RO7247669 to participants after the main study is over, in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    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 Decision2021-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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