Study of INCB086550 in Select Solid Tumors

NCT04629339 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: INCB 86550-203
• Study Type: interventional
• Target: 16
• Locations: 5 countries
• Sites: 20

Brief Summary

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

Conditions

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

Keywords

checkpoint inhibitor naive; Metastatic; PD-L1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), confirmed by ≥1 repeat assessment ≥28 days later, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

  up to 733 days

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  up to 733 days

• Duration of Response (DOR)

  up to 733 days

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to 823 days

• Number of Participants With Any ≥Grade 3 TEAE

  up to 823 days

Study Arms (1)

INCB086550

EXPERIMENTAL

INCB086550 will be administered orally twice a day.

Drug: INCB086550

Interventions

INCB086550 DRUG

INCB086550 will be administered orally twice a day.

INCB086550

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (20)

Complex Oncology Center - Burgas Eood

Burgas, 8000, Bulgaria

Location

Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc

Gabrovo, 5300, Bulgaria

Location

Complex Onclogy Center Plovdiv Eood

Plovdiv, 4004, Bulgaria

Location

Shatod Dr. Marko - Varna Ltd

Varna, 9000, Bulgaria

Location

Semmelweis Egyetem

Budapest, 1085, Hungary

Location

Complex Oncology Center - Burgas Eood

Farkasgyepű, 8582, Hungary

Location

Bacs Kiskun Megyei Oktatokorhaz

Kecskemét, 6000, Hungary

Location

The Catholic University of Korea St. Vincent'S Hospital

Gyeonggi-do, 16427, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Chang Gung Memorial Hospital Linkou

Taoyuan, 33305, Taiwan

Location

Multifield Clinical Hospital No 4

Dnipro, 49102, Ukraine

Location

Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

Kharkiv, 61166, Ukraine

Location

Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

Kryvyi Rih, 50048, Ukraine

Location

Volyn Regional Oncological Dispensary

Lutsk, 43018, Ukraine

Location

Rmi Sumy Regional Clinical Oncology Dispensary

Sumy, 40022, Ukraine

Location

Cne Ccch of Uzh Cc Oncological Center

Uzhhorod, 88000, Ukraine

Location

Medical Clinic Innovacia Llc

Vyshhorod, 07352, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Melanoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrollment in this study was discontinued after INCB086550 program development was terminated by the sponsor due to business reasons.

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: September 2, 2021
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

TW (1); BU (4); KR (5); UA (7); HU (3)