Study of INCB086550 in Select Solid Tumors

Study Overview
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Brief Summary
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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

Official Title
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A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors

Conditions
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Non Small Cell Lung Cancer, Urothelial Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma, Melanoma

Intervention / Treatment
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* Drug: INCB086550


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCB086550<br>INCB086550 will be administered orally twice a day. | Drug: INCB086550<br>* INCB086550 will be administered orally twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later according to RECIST v1.1 as determined by the investigator. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate | Defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later, or SD for ≥ 12 weeks, by investigator assessment per RECIST v1.1. | up to 2 years | 
| Duration of Response | Defined as the time from the earliest date of CR or PR confirmed by at least 1 repeat assessment ≥ 28 days later until the earliest date of disease progression by investigator assessment per RECIST v1.1, or death due to any cause, if occurring sooner than progression | up to 2 years | 
| Safety and Tolerability of INCB86550 as Assessed by Number of Participants With a TEAE | TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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checkpoint inhibitor naive, Metastatic, PD-L1