Study of INCB086550 in Select Solid Tumors (NCT04629339) | Clinical Trial Compass
TerminatedPhase 2
Study of INCB086550 in Select Solid Tumors
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.
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
Who can participate
Age range18 Years
SexALL
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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 stud…