Study of INCB086550 in Select Solid Tumors
Reason given: 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.
Key facts
- Where
- Dnipro, Kharkiv, Kryvyi Rih, Lutsk, Sumy, Uzhhorod, and Vyshhorod, UkraineSee the 7 sites
- Phase
- Phase 2
Where in Ukraine
- Multifield Clinical Hospital No 4Dnipro, UkraineNo longer taking part
- CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation ProtectionKharkiv, UkraineNo longer taking part
- Mi Kryviy Rih Center of Dnipropetrovsk Regional CouncilKryvyi Rih, UkraineNo longer taking part
- Volyn Regional Oncological DispensaryLutsk, UkraineNo longer taking part
- Rmi Sumy Regional Clinical Oncology DispensarySumy, UkraineNo longer taking part
- Cne Ccch of Uzh Cc Oncological CenterUzhhorod, UkraineNo longer taking part
- Medical Clinic Innovacia LlcVyshhorod, UkraineNo longer taking part
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT04629339
- Record updated
- 13 March 2025
- Original description
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 tumorsRead full original descriptionShow less
A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors
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
Inclusion: 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: 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; 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; 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; Active infection requiring systemic therapy; Participants who are known to be HIV-positive; Participants with impaired cardiac function or clinically significant cardiac disease; 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; Participants with laboratory values outside of protocol defined ranges Active malignancy of a type not included in the study population requiring treatment; 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); Untreated or known active CNS metastases and/or carcinomatous meningitis; Receipt of systemic antibiotics within 28 days of first dose of study treatment; Probiotic usage during screening and throughout the study treatment period; 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; Life expectancy < 3 months.