A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: INCB099280

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 02640
      • Border Medical Oncology Research Unit
  • Queensland
    • Townsville, Queensland, Australia, 04814
      • Townsville Cancer Centre
    • Woolloongabba, Queensland, Australia, 04102
      • Princess Alexandra Hospital Australia
  • Victoria
    • Box Hill, Victoria, Australia, 03128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 03168
      • Monash Medical Centre Clayton
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII Hospital de Câncer de Barretos
  • Florianópolis, Brazil, 88034-000
    • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
  • Ijuí, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica e Oncologia
  • Jaú, Brazil, 17210-120
    • Fundação Doutor Amaral Carvalho
  • Passo Fundo, Brazil, 99010-080
    • Hospital São Vicente de Paulo
  • Porto Alegre, Brazil, 90020-090
    • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Porto Alegre, Brazil, 90110-270
    • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Santa Cruz do Sul, Brazil, 96810-110
    • Instituto de Oncologia Saint Gallen
  • Santo André, Brazil, 09060-650
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • São Paulo, Brazil, 01509-900
    • A. C. Camargo Cancer Center
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Q.E. Ii Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Jewish General Hospital
• Chile
  • Santiago, Chile, 00000
    • CDIEM - Centro de Investigacion y Especialidades Medicas
  • Temuco, Chile, 4800827
    • James Lind Centro de Investigacion del Cancer
  • Valdivia, Chile, 5090000
    • Clinical Research Chile SpA.
• Croatia
  • Rijeka, Croatia, 51000
    • Specialty Hospital Medico
  • Zagreb, Croatia, 10000
    • University Hospital Centre Sestre Milosrdnice
• France
  • Bobigny, France, 93000
    • Avicenne Hospital
  • Bordeaux, France, 33075
    • Bordeaux Chu Hopital Saint - Andre
  • Boulogne-Billancourt, France, 92100
    • Hospital Ambroise Paré
  • Clermont-Ferrand, France, 63003
    • Chu de Clermont - Ferrand- Hospital Estaing
  • Dijon, France, 21079
    • Centre Georges François Leclerc
  • Dijon, France, 21079
    • CHU Dijon - Hôpital François Mitterrand
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
  • Lille, France, 59037
    • CHRU de Lille Hopital Claude Huriez
  • Marseille, France, 13385
    • CHU Hôpital de la Timone
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
  • Nice, France, 06200
    • Chu de Nice - Hospital L Archet
  • Paris, France, 75010
    • Hospital Saint Louis
  • Pau, France, 64046
    • Centre Hospitalier de Pau - Hôpital François Mitterrand
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Rouen, France, 76031
    • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
  • Saint-Etienne, France, 42055
    • University Hospital of Saint Etienne
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Hungary
  • Budapest, Hungary, 01085
    • Semmelweis Egyetem
  • Pécs, Hungary, 07632
    • Pécsi Tudományegyetem
• Montenegro
  • Podgorica, Montenegro, 81000
    • Clinical Center of Montenegro
• New Zealand
  • Hamilton, New Zealand, 03200
    • Waikato Hospital
• North Macedonia
  • Skopje, North Macedonia, 01000
    • University Clinic For Radiotherapy and Oncology
• Romania
  • Bucharest, Romania, 30463
    • S.C Policlinica Ccbr S.R.L
  • Cluj-Napoca, Romania, 400641
    • Medisprof
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Craiova, Romania, 200347
    • Centrul de Oncologie Sf. Nectarie Craiova
  • Suceava, Romania, 720284
    • S.C. Sigmedical Services Srl
  • Timișoara, Romania, 300239
    • Oncomed SRL
• South Africa
  • Centurion, South Africa, 01692
    • Johese Clinical Research: Midstream
  • Johannesburg, South Africa, 02193
    • Wits Clinical Research
  • Johannesburg, South Africa, 01864
    • Chris Hani Baragwanath Hospital
  • Johannesburg, South Africa, 02196
    • The Medical Oncology Centre of Rosebank
  • Port Elizabeth, South Africa, 06001
    • PHOENIX Pharma (Pty) Ltd
  • Pretoria, South Africa, 00084
    • University of Pretoria Oncology Department
• South Korea
  • Seongnam-si, South Korea, 13496
    • CHA Bundang Medical Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
• Spain
  • Badalona, Spain, 08916
    • Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08035
    • Hospital General Universitario Vall D Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona Main
  • El Palmar, Spain, 30120
    • Hospital Universitario Virgen de La Arrixaca
  • L'Hospitalet de Llobregat, Spain, 08906
    • Ico Institut Catala D Oncologia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28027
    • Clinical Universidad de Navarra Madrid
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra (CUN)
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01140
    • Medical Park Seyhan Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histopathological diagnosis of cSCC.
• Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
• Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy > 3 months.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Known history of an additional malignancy.
• Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
• Toxicity from prior therapy that has not recovered.
• Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
• Received thoracic radiation within 6 months of the first dose of study treatment.
• Participation in another interventional clinical study while receiving INCB099280.
• Impaired cardiac function or clinically significant cardiac disease.
• History or evidence of interstitial lung disease including noninfectious pneumonitis.
• Presence of gastrointestinal conditions that may affect drug absorption.
• Any autoimmune disease requiring systemic treatment in the past 5 years.
• Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
• Active infection requiring systemic therapy.
• History of organ transplantation, including allogeneic stem cell transplantation.
• Receipt of systemic antibiotics within 28 days of first dose of study treatment.
• Probiotic usage is prohibited during screening and throughout the study treatment period.
• Received a live vaccine within 28 days of the planned start of study drug.
• Laboratory values outside the Protocol-defined ranges.
• Inadequate organ function.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: INCB099280 Dose 1; Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.	Drug: INCB099280; Administered as specified in the treatment arm description.
Experimental: Part 1: INCB099280 Dose 2; Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.	Drug: INCB099280; Administered as specified in the treatment arm description.
Experimental: Part 2: INCB099280 Dose selected from Part 1; Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.	Drug: INCB099280; Administered as specified in the treatment arm description.
Experimental: Part 1: INCB099280 Dose 3; Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.	Drug: INCB099280; Administered as specified in the treatment arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Treatment-emergent Adverse Events (TEAEs)	Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.	Up to 2 years 3 months
Number of participants with TEAEs leading to dose modification or discontinuation	Number of participants with TEAEs leading to dose modification or discontinuation.	Up to 2 years
Objective response rate (ORR)	Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or composite criteria for metastatic cSCC and per World Health Organization (WHO) criteria for locally advanced cSCC.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
INCB099280 pharmacokinetic (PK) in Plasma	INCB099280 concentration in plasma	Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)
Disease Control Rate (DCR)	Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment as determined by the BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.	Up to 2 years
Duration Of Response (DOR)	Defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression, as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.	Up to 2 years
Time to Response (TTR)	Defined as the time from the date of first dose to the earliest date of confirmed CR or PR as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.	Up to 2 years
Progression-free survival (PFS)	Defined as the time from the date of first dose to the earliest date of disease progression as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.	Up to 2 years
Overall Survival (OS)	Defined as the time from the date of first dose to death due to any cause.	Up to 2 years

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

Helpful Links

• A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Anti-PD-L1 antibody; Cutaneous Squamous Cell Carcinoma; Metastatic cutaneous squamous cell carcinoma; Locally advanced cutaneous squamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: INCB 99280-212; 2022-502476-23-00 (Registry Identifier: EU CT Number)

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