Study of INCB086550 in Select Solid Tumors | NCT04629339 | Trialant
NCT04629339
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Mar 13, 2025Actual
Enrollment
16Actual
Phase
Phase 2
Conditions
Non Small Cell Lung Cancer
Urothelial Cancer
Renal Cell Carcinoma
Hepatocellular Carcinoma
Melanoma
Interventions
INCB086550
Countries
Bulgaria
Hungary
South Korea
Taiwan
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04629339
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 86550-203
Secondary IDs
Not provided
Brief Title
Study of INCB086550 in Select Solid Tumors
Official Title
A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic business decision to terminate the study effective immediately. This is due to a company decision to prioritize another oral PD-L1 inhibitor with a more favorable profile.
Expanded Access Info
No
Start Date
Sep 2, 2021Actual
Primary Completion Date
Mar 26, 2024Actual
Completion Date
Mar 26, 2024Actual
First Submitted Date
Nov 10, 2020
First Submission Date that Met QC Criteria
Nov 10, 2020
First Posted Date
Nov 16, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2025
Results First Submitted that Met QC Criteria
Feb 24, 2025
Results First Posted Date
Mar 13, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 24, 2025
Last Update Posted Date
Mar 13, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
An open-label, nonrandomized study to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of PD-L1, as initial immune checkpoint inhibitor therapy in participants with select solid tumors
Detailed Description
Not provided
Conditions Module
Conditions
Non Small Cell Lung Cancer
Urothelial Cancer
Renal Cell Carcinoma
Hepatocellular Carcinoma
Melanoma
Keywords
checkpoint inhibitor naive
Metastatic
PD-L1
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
16Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
INCB086550
Experimental
INCB086550 will be administered orally twice a day.
Drug: INCB086550
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB086550
Drug
INCB086550 will be administered orally twice a day.
INCB086550
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
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.
up to 733 days
Secondary Outcomes
Measure
Description
Time Frame
Disease Control Rate (DCR)
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ability to comprehend and willingness to sign a written ICF for the study.
Participants with following tumor types : non small cell lung cancer, renal cell carcinoma, urothelial carcinoma, hepatocellular carcinoma and melanoma
Measurable disease per RECIST v1.1.
ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.
Histologically or cytologically confirmed disease-specific diagnosis as per protocol.
Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
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).
Receipt of any anticancer therapy or participation in another interventional clinical study.
Radiotherapy within 14 days of first dose of study treatment.
Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers.
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). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with the medical monitor.
Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
Participants with laboratory values outside of protocol defined ranges Active malignancy of a type not included in the study population requiring treatment.
Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Untreated or known active CNS metastases and/or carcinomatous meningitis.
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).
Active infection requiring systemic therapy.
Receipt of systemic antibiotics within 28 days of first dose of study treatment
Probiotic usage during screening and throughout the study treatment period.
Participants who are known to be HIV-positive.
Participants with impaired cardiac function or clinically significant cardiac disease.
History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful.
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.
Has received a live vaccine within 90 days of the planned start of study drug.
Current use of a prohibited medication as described in protocol.
Life expectancy < 3 months.
Known hypersensitivity or severe reaction to any component of study drug or formulation components.
History of organ transplant, including allogeneic stem cell transplantation.
Inability to swallow tablets or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Complex Oncology Center - Burgas Eood
Burgas
8000
Bulgaria
Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 10 study centers in Hungary, Korea, and Ukraine.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
NSCLC 400 mg BID
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 8, 2021
Feb 24, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Romania
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
up to 733 days
Duration of Response (DOR)
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.
up to 733 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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.
up to 823 days
Number of Participants With Any ≥Grade 3 TEAE
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.
The Catholic University of Korea St. Vincent'S Hospital
Gyeonggi-do
16427
South Korea
Korea University Anam Hospital
Seoul
02841
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Asan Medical Center
Seoul
05505
South Korea
Ajou University Hospital
Suwon
16499
South Korea
Chang Gung Memorial Hospital Linkou
Taoyuan City
33305
Taiwan
Multifield Clinical Hospital No 4
Dnipro
49102
Ukraine
Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
Kharkiv
61166
Ukraine
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih
50048
Ukraine
Volyn Regional Oncological Dispensary
Lutsk
43018
Ukraine
Rmi Sumy Regional Clinical Oncology Dispensary
Sumy
40022
Ukraine
Cne Ccch of Uzh Cc Oncological Center
Uzhhorod
88000
Ukraine
Medical Clinic Innovacia Llc
Vyshhorod
07352
Ukraine
FG001
UC 400 mg BID
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.
FG002
RCC 400 mg BID
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.
FG003
Melanoma 400 mg BID
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.
FG004
Melanoma 400 mg BID Intermittent Dose
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.
FG0001 subjects
FG0011 subjects
FG0026 subjects
FG0037 subjects
FG0041 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0037 subjects
FG0040 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
Disease Progression
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
NSCLC 400 mg BID
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.
BG001
UC 400 mg BID
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.
BG002
RCC 400 mg BID
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.
BG003
Melanoma 400 mg BID
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.
BG004
Melanoma 400 mg BID Intermittent Dose
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0026
BG0037
BG0041
BG00516
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR)
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.
Full Analysis Set: all study participants who received ≥1 dose of study drug. Participants were analyzed according to the treatment group/dose to which they were assigned. Confidence intervals were calculated using the Clopper-Pearson method.
Posted
Number
95% Confidence Interval
percentage of participants
up to 733 days
ID
Title
Description
OG000
NSCLC 400 mg BID
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.
OG001
UC 400 mg BID
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.
OG002
RCC 400 mg BID
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.
OG003
Melanoma 400 mg BID
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.
OG004
Melanoma 400 mg BID Intermittent Dose
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.
Units
Counts
Participants
OG0001
OG0011
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 97.5)
OG001100.0(2.5 to 100.0)
OG0020.0(0.0 to 45.9)
OG003
Secondary
Disease Control Rate (DCR)
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.
Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method.
Posted
Number
95% Confidence Interval
percentage of participants
up to 733 days
ID
Title
Description
OG000
NSCLC 400 mg BID
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.
OG001
UC 400 mg BID
Secondary
Duration of Response (DOR)
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.
Full Analysis Set. Only participants with a CR or PR were analyzed.
Posted
Mean
Standard Deviation
months
up to 733 days
ID
Title
Description
OG000
NSCLC 400 mg BID
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.
OG001
UC 400 mg BID
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.
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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.
Safety Evaluable Population: all participants who received ≥1 dose of study drug. Treatment groups for this population were determined according to the actual treatment group/dose the participant received regardless of assigned study drug treatment.
Posted
Count of Participants
Participants
up to 823 days
ID
Title
Description
OG000
NSCLC 400 mg BID
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.
OG001
UC 400 mg BID
Secondary
Number of Participants With Any ≥Grade 3 TEAE
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.
Safety Evaluable Population
Posted
Count of Participants
Participants
up to 823 days
ID
Title
Description
OG000
NSCLC 400 mg BID
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.
OG001
UC 400 mg BID
Time Frame
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)
Description
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
NSCLC 400 mg BID
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.
1
1
0
1
1
1
EG001
UC 400 mg BID
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.
0
1
1
1
1
1
EG002
RCC 400 mg BID
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.
2
6
2
6
6
6
EG003
Melanoma 400 mg BID
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.
2
7
0
7
5
7
EG004
Melanoma 400 mg BID Intermittent Dose
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.
0
1
0
1
1
1
EG005
Total
Total
5
16
3
16
14
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected16 at risk
Immune-mediated neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected6 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected1 at risk
EG0053 events2 affected16 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events3 affected6 at risk
EG003
Arteriovenous fistula
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Brain compression
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events2 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Immune-mediated neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Ligamentum flavum hypertrophy
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0024 events2 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Pyelonephritis chronic
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected6 at risk
EG003
Enrollment in this study was discontinued after INCB086550 program development was terminated by the sponsor due to business reasons.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D008113
Liver Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D008107
Liver Diseases
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
0
BG0040
BG0050
Between 18 and 65 years
BG0000
BG0010
BG0024
BG0035
BG0041
BG00510
>=65 years
BG0001
BG0011
BG0022
BG0032
BG0040
BG0056
4
BG0033
BG0041
BG0058
Male
BG0001
BG0011
BG0022
BG0034
BG0040
BG0058
0
BG0030
BG0040
BG0050
Not Hispanic or Latino
BG0001
BG0011
BG0026
BG0037
BG0041
BG00516
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0030
BG0040
BG0050
Asian
BG0000
BG0010
BG0022
BG0030
BG0040
BG0052
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
White
BG0001
BG0011
BG0024
BG0037
BG0041
BG00514
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
7
OG0041
14.3
(0.4 to 57.9)
OG004100.0(2.5 to 100.0)
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.
OG002
RCC 400 mg BID
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.
OG003
Melanoma 400 mg BID
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.
OG004
Melanoma 400 mg BID Intermittent Dose
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.
Units
Counts
Participants
OG0001
OG0011
OG0026
OG0037
OG0041
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 97.5)
OG001100.0(2.5 to 100.0)
OG00250.0(11.8 to 88.2)
OG00328.6(3.7 to 71.0)
OG004100.0(2.5 to 100.0)
OG002
RCC 400 mg BID
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.
OG003
Melanoma 400 mg BID
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.
OG004
Melanoma 400 mg BID Intermittent Dose
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.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0041
Title
Denominators
Categories
Title
Measurements
OG0013.7± NAStandard deviation cannot be reported for a single participant.
OG0037.4± NAStandard deviation cannot be reported for a single participant.
OG00423.7± NAStandard deviation cannot be reported for a single participant.
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.
OG002
RCC 400 mg BID
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.
OG003
Melanoma 400 mg BID
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.
OG004
Melanoma 400 mg BID Intermittent Dose
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.
Units
Counts
Participants
OG0001
OG0011
OG0026
OG0037
OG0041
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0026
OG0035
OG0041
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.
OG002
RCC 400 mg BID
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.
OG003
Melanoma 400 mg BID
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.
OG004
Melanoma 400 mg BID Intermittent Dose
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.