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    Summary
    EudraCT Number:2020-000157-27
    Sponsor's Protocol Code Number:INCB86550-203
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-08
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-000157-27
    A.3Full title of the trial
    A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor–Naïve With Selected Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor–Naïve With Selected Solid Tumors
    A.4.1Sponsor's protocol code numberINCB86550-203
    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 Kingdom
    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 codeDE19803
    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.3.2Product code INCB086550
    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.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeINCB086550
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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
    Immune Checkpoint Inhibitor–Naïve Selected Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Immune Checkpoint Inhibitor–Naïve Selected Solid Tumors
    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 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    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 the ORR of participants treated with INCB086550.
    E.2.2Secondary objectives of the trial
    To determine the efficacy of INCB086550 in participants with advanced solid tumors in respect to DCR.
    To determine the efficacy of INCB086550 in participants with advanced solid tumors in respect to DOR.
    To evaluate the safety of INCB086550 in participants with advanced solid tumors.
    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 and women 18 years of age or older.
    3. Measurable disease per RECIST v1.1.
    4. ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.
    5. Histologically or cytologically confirmed disease-specific diagnosis as follows:
    a. Treatment-naïve, stage IV NSCLC (AJCC v8) in participants whose tumors express PD-L1 TPS ≥ 50% using the Dako PD-L1 IHC 22C3 assay and who have no known activating genomic aberrations that require targeted therapy (eg, EGFR, ALK, ROS, BRAF).
    b. Locally advanced, and unresectable or metastatic UC of the renal pelvis, ureter, bladder, or urethra (including transitional cell and mixed transitional or nontransitional cell histologies) in participants who are cisplatin-ineligible, who are immune checkpoint inhibitor–naïve, and whose tumors express high PD-L1 (CPS ≥ 10) using the Dako PD-L1 IHC 22C3 assay.
    c. Advanced HCC that is not amenable to curative surgery or local treatment in participants who have received at least 1 previous line of systemic therapy (ie, sorafenib or lenvatinib) or who were intolerant of sorafenib/lenvatinib treatment, have a Child-Pugh score of ≤ 6 (Child-Pugh A), and who are immune checkpoint inhibitor–naïve. Exception for HCC: Participants without access to prior systemic therapy (ie, sorafenib or lenvatinib).
    d. Advanced or metastatic RCC with a clear cell component with or without sarcomatoid features in participants who have received prior systemic therapy for their disease (up to 2 previous regimens of a VEGF or mTOR inhibitor) and who are immune checkpoint inhibitor–naïve.
    Exception for RCC: Participants without access to prior systemic therapy (ie, VEGF or mTOR inhibitors).
    e. Unresectable stage III or IV melanoma (excluding ocular/uveal melanoma) in participants who are immune checkpoint inhibitor–naïve. BRAF V600 mutation status must be known.
    Exception for melanoma: Participants may have received 1 prior line of
    therapy. This therapy could include previous
    treatment with BRAF/MEK inhibitors in participants with known BRAF V600 mutation or chemotherapy.
    6. Willingness to avoid pregnancy or fathering children (CTFG 2020).
    7. Participants must have radiologic documentation of disease
    progression after treatment with available therapies except for
    participants with NSCLC, who are required to be treatment-naïve.
    E.4Principal exclusion criteria
    1. Prior receipt of an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent, or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL2, 4-1BB, CAR-T).
    2. Receipt of any anticancer therapy or participation in another interventional clinical study.
    3. Radiotherapy within 14 days of first dose of study treatment (28 days for pelvic radiotherapy or 6 months for thoracic region radiotherapy that is > 30 Gy).
    4. Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers
    5. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia).
    6. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
    7. Participants with laboratory values at screening as defined in the protocol.
    8. Active malignancy of a type not included in the study population requiring treatment.
    9. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
    10. Evidence of interstitial lung disease or active, noninfectious pneumonitis.
    11. Untreated or known active CNS metastases and/or carcinomatous meningitis.
    12. With the exception of participants with HCC, known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization). Note: For participants with cleared prior HBV infection: HBV prophylaxis
    should be considered per investigator discretion. Monitor for HBV
    reactivation every 3 cycles by performing HBV viral load and HBsAg
    serology test. Additional viral serologic testing may be performed at the
    investigator's discretion.
    13. Active infection requiring systemic therapy.
    14. Receipt of systemic antibiotics within 28 days of first dose of study treatment.
    15. Probiotic usage during screening and throughout the study treatment period.
    16. Participants who are known to be HIV-positive.
    17. 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 ≤ 6 months before study participation.
    c. Acute myocardial infarction ≤ 6 months before study participation.
    d. Other clinically significant heart disease (ie, ≥ Grade 3 hypertension, history of labile hypertension, or poor compliance with an antihypertensive regimen) must have recovered (to baseline or ≤ Grade 1) from toxicity associated with prior treatment.
    18. History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful. sponsor approval.
    19. Female participant is pregnant or breastfeeding within the projected duration of the study, starting with the screening visit through the 90-day safety follow-up, or male participant is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 100 days after the last dose of study treatment.
    20. Has received a live vaccine within 90 days of the planned start of study drug.
    21. Current use of a prohibited medication as described in the protocol.
    22. Life expectancy < 3 months.
    23. Known hypersensitivity or severe reaction to any component of study drug or formulation components.
    24. History of organ transplant, including allogeneic stem cell transplantation.
    25. Presence of gastrointestinal condition that may affect drug absorption.
    26. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
    E.5 End points
    E.5.1Primary end point(s)
    ORR, defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later according to RECIST v1.1 as determined by the investigator.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and endpoint assessments will be performed throughout the
    study.
    E.5.2Secondary end point(s)
    DCR, defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later, or SD for ≥ 12 weeks, by investigator assessment per RECIST v1.1.
    DOR, defined as the time from the earliest date of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later until the earliest date of disease progression by investigator assessment per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
    Safety is determined by monitoring the frequency and severity of AEs, including the evaluation of laboratory tests, vital signs, and ECGs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint assessments will be performed throughout the study. Disease
    assessments will be made every 8 weeks for the first 12 months and
    then every 12 weeks.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Korea, Republic of
    Russian Federation
    Serbia
    Taiwan
    Ukraine
    Bulgaria
    Hungary
    Romania
    E.8.7Trial has a data monitoring committee Yes
    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 years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 152
    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 80
    F.4.2.2In the whole clinical trial 304
    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 Decision2020-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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