Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Hepatocellular

Melanoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

INCB086550 will be administered orally twice a day.

INCB086550

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

Study of INCB086550 in Select Solid Tumors

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

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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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.

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.

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

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.

Incyte Corporation

INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.

Kevin O'Hayer, MD, PhD

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Maximum observed plasma or serum concentration.

Area under the plasma or serum concentration-time curve from time = 0 to the end of dosing period at steady state

Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity

Apparent terminal-phase disposition half-life.

Apparent terminal-phase disposition rate constant

Apparent oral dose volume of distribution.

Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.

Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or response assessment in Neuro-Oncology (RANO).

Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1 or response assessment in Neuro-Oncology (RANO).

Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 for response assessment in Neuro-Oncology (RANO), or death due to any cause, if occurring sooner than progression.

Minimum observed plasma or serum concentration of INCB086550

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of INCB086550 in Select Solid Tumors	NCT04629339	Non Small Cell ... Urothelial Canc... Renal Cell Carc... Hepatocellular ... Melanoma	INCB086550	18 Years -	Incyte Corporation
Study of INCB086550 in Select Solid Tumors	NCT04629339	Non Small Cell ... Urothelial Canc... Renal Cell Carc... Hepatocellular ... Melanoma	INCB086550	18 Years -	Incyte Corporation
A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors	NCT03762447	Solid Tumors	INCB086550	18 Years -	Incyte Corporation
Study of INCB086550 in Select Solid Tumors	NCT04629339	Non Small Cell ... Urothelial Canc... Renal Cell Carc... Hepatocellular ... Melanoma	INCB086550	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for incb086550

Every month we try and update this database with for incb086550 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for incb086550

Every month we try and update this database with for incb086550 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incb086550 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.