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

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 Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Renal Cell Carcinoma; Hepatocellular Carcinoma; Non Small Cell Lung Cancer; Urothelial Cancer
• Intervention / Treatment: Drug: INCB086550

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8000
    • Complex Oncology Center - Burgas Eood
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc
  • Plovdiv, Bulgaria, 4004
    • Complex Onclogy Center Plovdiv Eood
  • Varna, Bulgaria, 9000
    • Shatod Dr. Marko - Varna Ltd
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem
  • Farkasgyepu, Hungary, 8582
    • Complex Oncology Center - Burgas Eood
  • Kecskemet, Hungary, 6000
    • Bacs Kiskun Megyei Oktatokorhaz
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 16427
    • The Catholic University of Korea St. Vincent's Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital
• Taiwan
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Memorial Hospital Linkou
• Ukraine
  • Dnipro, Ukraine, 49102
    • Multifield Clinical Hospital No 4
  • Kharkiv, Ukraine, 61166
    • CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection
  • Kryvyi Rih, Ukraine, 50048
    • MI Kryviy Rih Center of Dnipropetrovsk Regional Council
  • Lutsk, Ukraine, 43018
    • Volyn Regional Oncological Dispensary
  • Sumy, Ukraine, 40022
    • RMI Sumy Regional Clinical Oncology Dispensary
  • Uzhgorod, Ukraine, 88000
    • Cne Ccch of Uzh Cc Oncological Center
  • Vyshhorod, Ukraine, 07352
    • Medical Clinic Innovacia Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCB086550; INCB086550 will be administered orally twice a day.	Drug: INCB086550; INCB086550 will be administered orally twice a day.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Estimated): March 6, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic; PD-L1; checkpoint inhibitor naive
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: INCB 86550-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No