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Clinical Trials List

Protocol NumberINCB 86550-203
NCT Number(ClinicalTrials.gov Identfier)NCT04629339

2020-11-01 - 2022-03-11

Phase II

Recruiting3

Terminated4

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Incyte Corporation

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shu-Pin Huang Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 曹朝榮 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 康智雄 Division of Urology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tsai-Sheng Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Non Small Cell Lung Cancer / Urothelial Cancer / Renal Cell Carcinoma / Hepatocellular Carcinoma / Melanoma

Objectives

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.

Test Drug

INCB086550

Active Ingredient

INCB086550

Dosage Form

Tablet

Dosage

100 mg

Endpoints

Primary Outcome Measures :
1.Objective Response Rate

Secondary Outcome Measures:
1.Disease Control Rate
2.Duration of Response
3.Safety and Tolerability of INCB86550 as Assessed by Number of Participants With a TEAE

Inclution Criteria

1.Ability to comprehend and willingness to sign a written ICF for the study.
2.Participants with following tumor types : non small cell lung cancer, renal cell carcinoma, urothelial carcinoma, hepatocellular carcinoma and melanoma
3.Measurable disease per RECIST v1.1.
4.ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.
5.Histologically or cytologically confirmed disease-specific diagnosis as per protocol.
6.Willingness to avoid pregnancy or fathering children

Exclusion Criteria

1.Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL2, 4-1BB, CAR-T).
2.Receipt of any anticancer therapy or participation in another interventional clinical study.
3.Radiotherapy within 14 days of first dose of study treatment.
4.Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers.
5.Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with the medical monitor.
6.Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
7.Participants with laboratory values outside of protocol defined ranges Active malignancy of a type not included in the study population requiring treatment.
8.Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
9.Evidence of interstitial lung disease or active, noninfectious pneumonitis.
10.Untreated or known active CNS metastases and/or carcinomatous meningitis.
11.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).
12.Active infection requiring systemic therapy.
13.Receipt of systemic antibiotics within 28 days of first dose of study treatment
14.Probiotic usage during screening and throughout the study treatment period.
15.Participants who are known to be HIV-positive.
16.Participants with impaired cardiac function or clinically significant cardiac disease.
17.History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful.
18.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.
19.Has received a live vaccine within 90 days of the planned start of study drug.
20.Current use of a prohibited medication as described in protocol.
Life expectancy < 3 months.
21.Known hypersensitivity or severe reaction to any component of study drug or formulation components.
22.History of organ transplant, including allogeneic stem cell transplantation.
23.Inability to swallow tablets or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
24.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.

The Estimated Number of Participants

  • Taiwan

    28 participants

  • Global

    304 participants

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