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    Summary
    EudraCT Number:2022-000631-23
    Sponsor's Protocol Code Number:BP43963
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-30
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-000631-23
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE II STUDY OF MULTIPLE DOSES OF RO7247669 IN PARTICIPANTS WITH PREVIOUSLY UNTREATED UNRESECTABLE OR METASTATIC MELANOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Multiple Doses of RO7247669 in Participants with Previously Untreated Unresectable or Metastatic Melanoma
    A.4.1Sponsor's protocol code numberBP43963
    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-LAG3
    D.3.2Product code RO7247669/F01-01
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameRO7247669
    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.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
    Unresectable or Metastatic Melanoma
    E.1.1.1Medical condition in easily understood language
    Melanoma is a type of skin cancer which develops when the cells that control pigment of the skin (melanocytes) become cancerous.
    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 10027481
    E.1.2Term Metastatic melanoma
    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 clinical activity of RO7247669 at 600 mg and 1200 mg every 3 weeks (Q3W) on the basis of progression-free survival (PFS)
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of RO7247669 at 600 mg and 1200 mg Q3W
    • To evaluate the clinical activity of RO7247669 at 600 mg and 1200 mg Q3W on the basis of objective response rate (ORR), disease control rate (DCR) and duration of response (DoR) for participants with objective response
    • To investigate the pharmacokinetics (PK) of RO7247669 at 600 mg and 1200 mg Q3W
    • To evaluate the immune response after administration of RO7247669 at 600 mg and 1200 mg Q3W
    • To evaluate potential effects of anti-drug antibodies (ADAs)
    • To assess treatment-induced pharmacodynamic changes (PD biomarkers) in peripheral blood and tumor microenvironment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General
    • Age >= 18 years
    Type of Participants and Disease Characteristics
    • Participants must have histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system
    • Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (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
    • Participants must have known v-Raf murine sarcoma viral oncogene homolog B1(BRAF) V600 mutation status
    • Participants must have known programmed death-ligand 1 (PD-L1) status by a documented local assessment as determined by plasma
    membrane PD-L1 IHC staining of any intensity in tumor cells on a tissue sample obtained within 3 months prior to enrollment and with no
    intervening treatment between time of tissue sample acquisition and PD L1 testing. In case PD-L1 status is unknown, the assessment can be
    done centrally using the Ventana SP263 IHC assay
    • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses.
    • Participants must have at least one non-target tumor lesion accessible to biopsy per clinical judgment of the treating physician and consent undergo mandatory on treatment biopsy
    Medical Conditions
    • Adequate cardiovascular, hematological, liver, renal function and laboratory parameters
    • Adverse events (AEs) from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade <=1, except alopecia, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy
    Contraception
    • Male and/or female participants: The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment. The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence and withdrawal are not acceptable methods of contraception
    • Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding
    • Male participants: During the treatment period and for at least 4 months after the final dose of study drug
    E.4Principal exclusion criteria
    General
    • Pregnancy, lactation, or breastfeeding
    • Known hypersensitivity to any of the components of RO7247669 including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
    Type of Participants and Disease Characteristics
    • Participants must not have ocular melanoma
    Medical Conditions
    • Symptomatic central nervous system (CNS) metastases. Participants with previously treated brain 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
    • Participants with an active second malignancy. Concurrent malignancy exceptions include curatively treated carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal or squamous cell skin cancer, or low grade, early stage localized prostate cancer and any previously treated early-stage non-hematological malignancy that has been in remission for at least two years
    • 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
    • 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, parasitic, or other infection, or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization 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 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, pericardial effusion, or ascites requiring recurrent drainage procedures
    • 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. Participants with a positive HBsAg or total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening are eligible
    • Positive hepatitis C virus (HCV) antibody test at screening. Participants with a positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible
    Prior/Concomitant Therapy
    • Prior systemic anticancer therapy for unresectable or metastatic melanoma
    • Prior anticancer therapy with any immunomodulatory agents including checkpoint inhibitors (CPI)
    • Prior treatment with anti- lymphocyte activation gene 3 (LAG3) therapy
    • Any history of life-threatening toxicity related to prior immune therapy except those that are unlikely to re-occur with standard countermeasures
    • 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 < 28 days or 5 half-lives of the drug prior to randomization
    • Treatment with immune-modulating and immune suppressive agents/medication < 5 half-lives or 28 days prior to randomization
    • Regular immunosuppressive therapy
    • Radiotherapy within the last 28 days before start of treatment with RO7247669 is not allowed, with the exception of limited palliative radiotherapy
    • Prior treatment with adoptive cell therapies, such as chimeric antigen receptor T-cell (CAR-T) therapies
    E.5 End points
    E.5.1Primary end point(s)
    1. PFS defined as the time from randomization to the first occurrence of progression as determined by the Investigator 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 24 months
    E.5.2Secondary end point(s)
    1. Nature, frequency, and severity of AEs graded according to the 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 + stable disease rate (SDR)
    4. DoR for participants with objective response, 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. Serum concentrations, PK profiles and parameters for RO7247669
    6. Incidence and titer of RO7247669 ADAs during the study relative to the prevalence of ADA at baseline
    7. Relationship between ADA status and PK, safety, pharmacodynamics, and efficacy
    8. Changes from baseline in the phenotype and activation status of T cell subsets in the peripheral blood (CD4/CD8 HLA-DR+/Ki67+) changes from baseline in the tumor microenvironment (such as CD8 T-cell infiltration)
    9. Proliferation (CD8+Ki67+)
    10. Changes from baseline in the tumor microenvironment (such as CD8 T cell infiltration, proliferation (CD8+Ki67+))
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Up to approximately 24 months
    5. At Days 1, 8, 15 of Cycle 1, Days 1, 5 of Cycle 2, Day 1 of Cycles 3 and 4, Days 1, 8, 15 of Cycle 5 and Day 1 of every other cycle until the end of treatment, at treatment discontinuation
    6. At Predose of Cycles 1, 2, 3, 4, 5, 7 and then every 2 cycles until the end of treatment
    7. Up to approximately 24 months
    8-10. Baseline up to approximately 24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    same drug, different dose
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Israel
    New Zealand
    Poland
    Sweden
    Netherlands
    Spain
    Switzerland
    Czechia
    Germany
    Italy
    Belgium
    Denmark
    Hungary
    Russian Federation
    Turkey
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study including the survival follow up period.
    The end of the study is defined as the date when the last participant last observation (LPLO occurs). LPLO is expected to occur at the latest 24 months after the last participant is randomized.
    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 months0
    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 months5
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 80
    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 RO7247669 or any other study treatment or interventions to participants after conclusion of the study or in the event of an earlier participant withdrawal. The Sponsor will evaluate whether to continue to provide study treatment to participants after the main study is over, in accordance with the Roche Global Policy on Continued Access to IMP, available on the website that can be found in section 6.7 of the protocol
    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 Decision2022-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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