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    Summary
    EudraCT Number:2020-002244-23
    Sponsor's Protocol Code Number:INCB24360-901
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-26
    Trial results View 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 number2020-002244-23
    A.3Full title of the trial
    An Open-Label, Randomized, Phase 2, Umbrella Study of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy (Optimus)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label, Randomized, Phase 2, Study of Various Therapies for Participants With Muscle-Invasive bladder cancer who are not eligible for Cisplatin or Refuse Cisplatin Therapy and are having bladder removal. (Optimus)
    A.3.2Name or abbreviated title of the trial where available
    Optimus
    A.4.1Sponsor's protocol code numberINCB24360-901
    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 SponsorIncyte Corporation
    B.1.3.4CountryUnited States
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRegAffairs@incyte.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 nameepacadostat
    D.3.2Product code INCB024360
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeINCB024360
    D.3.9.3Other descriptive nameINCB024360
    D.3.9.4EV Substance CodeSUB117263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 nameretifanilimab
    D.3.2Product code INCMGA00012
    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.3.9.2Current sponsor codeINCMGA00012
    D.3.9.3Other descriptive nameINCMGA00012
    D.3.9.4EV Substance CodeSUB193740
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy
    E.1.1.1Medical condition in easily understood language
    Muscle-Invasive Bladder cancer Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and having bladder removal
    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 10064467
    E.1.2Term Urothelial carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046714
    E.1.2Term Urothelial carcinoma bladder
    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 determine biologic response in participants with muscle-invasive cisplatin-ineligible or those refusing cisplatin therapy, urothelial carcinoma of
    the bladder.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of each of the treatment groups.
    To evaluate the preliminary efficacy of each of the treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to comprehend and willingness to sign a written ICF for the study.
    2. Men or women aged 18 years or older.
    3. Histologically confirmed transitional cell urothelial carcinoma.
    4. Clinical stage T2-T3b, N0, M0 muscle invasive urothelial carcinoma by CT (or MRI) + PET/CT (Stage II-IIIA per AJCC 2018).
    a. Concomitant upper tract tumors should be excluded.
    5. Ineligible for cisplatin therapy per modified Galsky criteria with exclusion of ECOG PS 2 participants
    a. Participants with CTCAE v4 ≥ Grade 2 audiometric hearing loss (Galsky Criteria).
    b. Participants with CTCAE v4 ≥ Grade 2 peripheral neuropathy (Galsky Criteria).
    c. Creatinine clearance of < 60 mL/min but ≥ 30 mL/min (measured by the
    Cockcroft-Gault formula or 24-hour urine).
    d. New York Heart Association Class III heart failure.
    6. Participants who refuse cisplatin-based therapy.
    7. Eligible for radical cystectomy by the following:
    a. Fit and planned for radical cystectomy according to local guidelines.
    b. Able to receive a minimum of 4 weeks of neoadjuvant treatment on study before date of scheduled radical cystectomy.
    c. Willing and able to delay surgery by a maximum of 12 weeks, if necessary.
    8. Residual disease after TURBT
    9. ECOG PS 0 or 1.
    10. Pretreatment tumor biopsy must be a tumor block or 20 unstained slides from biopsy of primary tumor containing at least 20% tumor.
    11. Willingness to avoid pregnancy or fathering children based on the criteria below.
    a. Male participants with childbearing potential must agree to take appropriate
    precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug and must refrain from donating sperm during this period.
    b. Women participants with childbearing potential must have a negative serum and/or pregnancy test at screening and before the first dose of study drug on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) and from donating oocytes from screening through 90 days after last dose of study drug.
    c. Women participants without childbearing potential (ie, surgically sterile with a
    hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea).
    d. Women participants without childbearing potential should refrain from donating oocytes from screening through 90 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Participation in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) before first dose.
    2. Previously received systemic therapy for bladder cancer or received prior treatment with checkpoint inhibitor agents (such as anti–PD-1, anti–PD-L1, anti–PD-L2, or anti–CTLA-4).
    3. Evidence of measurable nodal or metastatic disease.
    4. Concurrent anticancer therapy
    5. Has had major surgery within 4 weeks before enrollment (C1D1).
    6. Has had known additional malignancy other than miUBC that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
    7. Has active autoimmune disease requiring systemic immunosuppression with
    corticosteroids (> 10 mg daily doses of prednisone or equivalent) or immunosuppressive drugs within 2 years of Day 1 of study treatment.
    8. Participants with laboratory values at screening defined in the protocol
    9. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or equivalent).
    10. Has known active hepatitis B or C (defined as follows) or HIV, HBV, HCV, or hepatitis D virus coinfection:
    a. Active hepatitis B infection is defined by positive HBsAg and positive total anti-HBc results.
    b. Active hepatitis C is defined by a positive hepatitis C antibody result and
    quantitative HCV RNA results greater than lower limits of detection of the assay.
    11. Participants who are known to be HIV-positive, unless all of the following criteria are met:
    a. CD4+ count ≥ 300/μL.
    b. Undetectable viral load.
    c. Receiving antiretroviral therapy that is not a potential risk for a drug-drug interaction with the assigned study drugs.
    12. Has known carcinomatous meningitis.
    13. Active infection requiring systemic antibiotics ≤ 14 days from first dose of study drug.
    14. Participants with known or suspected COVID-19 infection.
    15. Use of probiotics within 28 days from first dose of study drug.
    16. Current use of prohibited medication
    17. Has not recovered to ≤ Grade 1 from toxic effects of previous therapy and/or
    complications from previous surgical intervention before starting study therapy.
    18. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
    19. History of a gastrointestinal condition (eg, inflammatory bowel disease, Crohn disease, ulcerative colitis) that may affect oral drug absorption.
    20. Has received a live vaccine within 30 days of planned start of study therapy.
    21. Participants with impaired cardiac function or clinically significant cardiac disease:
    a. New York Heart Association Class III or IV cardiac disease, including preexisting
    clinically significant ventricular arrhythmia, congestive heart failure, or
    cardiomyopathy
    b. Unstable angina pectoris.
    c. Acute myocardial infarction ≤ 6 months before study participation.
    d. Other clinically significant heart disease (eg, ≥ Grade 3 hypertension).
    22. Inability or unlikeliness to comply with the dose schedule and study evaluations, in the opinion of the investigator.
    23. For participants who will receive retifanlimab:
    a. Evidence of interstitial lung disease or active, noninfectious pneumonitis.
    b. Has known hypersensitivity to any of the study drugs, excipients, including mannitol or another monoclonal antibody which cannot be controlled with standard measures
    c. Any ≥ Grade 2 immune-related toxicity while receiving prior immunotherapy.
    24. For participants who will receive epacadostat:
    a. History of serotonin syndrome after receiving 1 or more serotonergic drugs.
    b. Concomitant use of medications that are known to be substrates of CYP1A2,
    CYP2C8, or CYP2C19 with narrow therapeutic window are prohibited
    c. Patients who are receiving or required to receive medications that are known to be UGT1A9 inhibitor
    25. For participants enrolled in France, the following are excluded: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
    E.5 End points
    E.5.1Primary end point(s)
    For each treatment group, the primary endpoint is the change from baseline in CD8+ lymphocytes within resected tumor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be performed throughout the study and the primary end point will be evaluated at the time of radical cystectomy
    E.5.2Secondary end point(s)
    • Safety and tolerability assessed by monitoring the frequency and severity of AEs, including delay in cystectomy due to AEs
    •pCR rate, defined as percentage of participants with ypT0N0 in each treatment
    group.
    • Major pathological response, defined as residual ypT0/1/a/isN0M0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety will be performed throughout the study and the primary end point will be evaluated at the time of radical cystectomy
    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 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
    Translational - the primary endpoint is the change from baseline in CD8+ lymphocytes within resected tumor.
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    United States
    France
    Italy
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 45
    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 Decision2021-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-29
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