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    Clinical Trial Results:
    A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor–Naïve With Selected Solid Tumors

    Summary
    EudraCT number
    		 2020-000157-27
    Trial protocol
    		 HU   BG   RO  
    Global end of trial date
    26 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2025
    First version publication date
    15 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCB 86550-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was conducted to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of programmed death-ligand 1 (PD-L1), as an initial immune checkpoint inhibitor therapy in participants with select solid tumors.
    Protection of trial subjects
    This study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Ukraine: 13
    Worldwide total number of subjects
    16
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at 10 study centers in Hungary, Korea, and Ukraine.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NSCLC 400 mg BID
    Arm description
    		 Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB086550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally in 100 mg tablets

    Arm title
    		 UC 400 mg BID
    Arm description
    		 Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB086550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally in 100 mg tablets

    Arm title
    		 RCC 400 mg BID
    Arm description
    		 Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB086550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally in 100 mg tablets

    Arm title
    		 Melanoma 400 mg BID
    Arm description
    		 Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB086550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally in 100 mg tablets

    Arm title
    		 Melanoma 400 mg BID Intermittent Dose
    Arm description
    		 Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB086550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally in 100 mg tablets

    Number of subjects in period 1
    		NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose
    Started
    1
    1
    6
    7
    1
    Completed
    0
    0
    1
    0
    1
    Not completed
    1
    1
    5
    7
    0
         Adverse event, serious fatal
    1
    -
    2
    2
    -
         Physician decision
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    2
    2
    -
         Study Terminated by Sponsor
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    -
    1
    -
         Disease Progression
    -
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NSCLC 400 mg BID
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    UC 400 mg BID
    Reporting group description
    		 Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    RCC 400 mg BID
    Reporting group description
    		 Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Melanoma 400 mg BID
    Reporting group description
    		 Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Melanoma 400 mg BID Intermittent Dose
    Reporting group description
    		 Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group values
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose Total
    Number of subjects
    		 1 1 6 7 1 16
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0 0 0 0
        Between 18 and 65 years
    		 0 0 4 5 1 10
        >=65 years
    		 1 1 2 2 0 6
    Sex: Female, Male
    Units: participants
        Female
    		 0 0 4 3 1 8
        Male
    		 1 1 2 4 0 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 0 0 2 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0
        White
    		 1 1 4 7 1 14
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0 0
        Not Hispanic or Latino
    		 1 1 6 7 1 16
        Unknown or Not Reported
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    NSCLC 400 mg BID
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    UC 400 mg BID
    Reporting group description
    		 Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    RCC 400 mg BID
    Reporting group description
    		 Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Melanoma 400 mg BID
    Reporting group description
    		 Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Melanoma 400 mg BID Intermittent Dose
    Reporting group description
    		 Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), confirmed by ≥1 repeat assessment ≥28 days later, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Confidence intervals were calculated using the Clopper-Pearson method.
    End point type
    Primary
    End point timeframe
    up to 733 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose
    Number of subjects analysed
    1 [2]
    1 [3]
    6 [4]
    7 [5]
    1 [6]
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 97.5)
    100.0 (2.5 to 100.0)
    0.0 (0.0 to 45.9)
    14.3 (0.4 to 57.9)
    100.0 (2.5 to 100.0)
    Notes
    [2] - Full Analysis Set: all study participants who received ≥1 dose of study drug
    [3] - Full Analysis Set: all study participants who received ≥1 dose of study drug
    [4] - Full Analysis Set: all study participants who received ≥1 dose of study drug
    [5] - Full Analysis Set: all study participants who received ≥1 dose of study drug
    [6] - Full Analysis Set: all study participants who received ≥1 dose of study drug
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    DCR was defined as the percentage of participants with a best overall response of CR or PR, confirmed by ≥1 repeat assessment ≥28 days later, or stable disease (SD) for ≥12 weeks, by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Progressive disease (PD): progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. Confidence intervals were calculated using the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    up to 733 days
    End point values
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose
    Number of subjects analysed
    1 [7]
    1 [8]
    6 [9]
    7 [10]
    1 [11]
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 97.5)
    100.0 (2.5 to 100.0)
    50.0 (11.8 to 88.2)
    28.6 (3.7 to 71.0)
    100.0 (2.5 to 100.0)
    Notes
    [7] - Full Analysis Set
    [8] - Full Analysis Set
    [9] - Full Analysis Set
    [10] - Full Analysis Set
    [11] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the time from the earliest date of CR or PR, confirmed by ≥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. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. 9999=Standard deviation cannot be reported for a single participant.
    End point type
    Secondary
    End point timeframe
    up to 733 days
    End point values
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose
    Number of subjects analysed
    0 [12]
    1 [13]
    0 [14]
    1 [15]
    1 [16]
    Units: months
        arithmetic mean (standard deviation)
    ( )
    3.7 ( 9999 )
    ( )
    7.4 ( 9999 )
    23.7 ( 9999 )
    Notes
    [12] - Full Analysis Set. Only participants with a CR or PR were analyzed.
    [13] - Full Analysis Set. Only participants with a CR or PR were analyzed.
    [14] - Full Analysis Set. Only participants with a CR or PR were analyzed.
    [15] - Full Analysis Set. Only participants with a CR or PR were analyzed.
    [16] - Full Analysis Set. Only participants with a CR or PR were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-emergent adverse event (TEAE)

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    End point title
    		 Number of participants with any treatment-emergent adverse event (TEAE)
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first.
    End point type
    Secondary
    End point timeframe
    up to 823 days
    End point values
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose
    Number of subjects analysed
    1 [17]
    1 [18]
    6 [19]
    7 [20]
    1 [21]
    Units: participants
    1
    1
    6
    5
    1
    Notes
    [17] - Safety Evaluable Population: all participants who received ≥1 dose of study drug.
    [18] - Safety Evaluable Population: all participants who received ≥1 dose of study drug.
    [19] - Safety Evaluable Population: all participants who received ≥1 dose of study drug.
    [20] - Safety Evaluable Population: all participants who received ≥1 dose of study drug.
    [21] - Safety Evaluable Population: all participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Number of participants with any ≥Grade 3 TEAE

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    End point title
    		 Number of participants with any ≥Grade 3 TEAE
    End point description
    A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
    End point type
    Secondary
    End point timeframe
    up to 823 days
    End point values
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose
    Number of subjects analysed
    1 [22]
    1 [23]
    6 [24]
    7 [25]
    1 [26]
    Units: participants
    0
    1
    3
    0
    0
    Notes
    [22] - Safety Evaluable Population
    [23] - Safety Evaluable Population
    [24] - Safety Evaluable Population
    [25] - Safety Evaluable Population
    [26] - Safety Evaluable Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
    Adverse event reporting additional description
    Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    NSCLC 400 mg BID
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    UC 400 mg BID
    Reporting group description
    		 Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    RCC 400 mg BID
    Reporting group description
    		 Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Melanoma 400 mg BID
    Reporting group description
    		 Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Melanoma 400 mg BID Intermittent Dose
    Reporting group description
    		 Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    3 / 16 (18.75%)
         number of deaths (all causes)
    1
    0
    2
    2
    0
    5
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Immune-mediated neuropathy
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 NSCLC 400 mg BID UC 400 mg BID RCC 400 mg BID Melanoma 400 mg BID Melanoma 400 mg BID Intermittent Dose Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    6 / 6 (100.00%)
    5 / 7 (71.43%)
    1 / 1 (100.00%)
    14 / 16 (87.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Cerebral haemangioma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Haemangioma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Uterine leiomyoma
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    4
    0
    4
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    3
    0
    0
    3
    Oedema peripheral
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    3
    1
    0
    4
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    1
    0
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Nervous system disorders
    Brain compression
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    2
    4
    0
    6
    Hypoaesthesia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Immune-mediated neuropathy
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 6 (50.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    4 / 16 (25.00%)
         occurrences all number
    0
    0
    3
    1
    0
    4
    Thrombocytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    4
    0
    0
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    1
    1
    0
    2
    Rash
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Back pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Ligamentum flavum hypertrophy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Osteoporosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Osteochondrosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    1
    0
    1
    4
    0
    6
    Scoliosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Infections and infestations
    Coronavirus infection
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    1
    2
    0
    3
    Cystitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    3
    0
    0
    3
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    0
    0
    2
    Decreased appetite
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2021
    The primary purpose of this amendment was to incorporate additional dose levels to evaluate the safety and preliminary activity of INCB086550 with intermittent and/or step-down dose administration schedules.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Enrollment in this study was discontinued after INCB086550 program development was terminated by the sponsor due to business reasons.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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