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: Recruiting
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: INCB099280

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 02640
      • Recruiting
      • Border Medical Oncology Research Unit
  • Queensland
    • Townsville, Queensland, Australia, 04814
      • Recruiting
      • Townsville Cancer Centre
    • Woolloongabba, Queensland, Australia, 04102
      • Recruiting
      • Princess Alexandra Hospital Australia
  • Victoria
    • Bendigo, Victoria, Australia, 03550
      • Withdrawn
      • Bendigo Hospital
    • Box Hill, Victoria, Australia, 03128
      • Recruiting
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 03168
      • Recruiting
      • Monash Medical Centre Clayton
• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Fundacao Pio Xii Hospital de Cancer de Barretos
  • Florianópolis, Brazil, 88034-000
    • Recruiting
    • Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
  • Ijui, Brazil, 98700-000
    • Recruiting
    • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • JAÚ, Brazil, 17210-120
    • Recruiting
    • Fundacao Doutor Amaral Carvalho
  • Passo Fundo, Brazil, 99010-080
    • Recruiting
    • Hospital Sao Vicente de Paulo
  • Porto Alegre, Brazil, 90035-903
    • Not yet recruiting
    • Hospital de Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90020-090
    • Recruiting
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 91350-200
    • Not yet recruiting
    • Hospital Nossa Senhora da Conceicao
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Salvador, Brazil, 40170110
    • Not yet recruiting
    • Nob - Nucleo de Oncologia Da Bahia
  • Santa Cruz Do Sul, Brazil, 96810-110
    • Recruiting
    • Instituto de Oncologia Saint Gallen
  • Santo André, Brazil, 09060-650
    • Not yet recruiting
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Sao Jose Do Rio Preto, Brazil, 15090-000
    • Not yet recruiting
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • São Paulo, Brazil, 01246-000
    • Not yet recruiting
    • Instituto Do Cancer de Sao Paulo - Icesp
  • São Paulo, Brazil, 01509-900
    • Recruiting
    • A. C. Camargo Cancer Center
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Not yet recruiting
      • Q.E. Ii Health Sciences Centre
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Not yet recruiting
      • Toronto Sunnybrook Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Not yet recruiting
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Jewish General Hospital
• Chile
  • Santiago, Chile, 13127
    • Not yet recruiting
    • Centro de Investigacion Clinica Bradford Hill
  • Santiago, Chile, 00000
    • Recruiting
    • Cdiem - Centro de Investigacion Y Especialidades Medicas
  • Temuco, Chile, 4800827
    • Recruiting
    • James Lind Centro de Investigación del Cáncer
  • Valdivia, Chile, 5090000
    • Recruiting
    • Clinical Research Chile Spa.
• Colombia
  • Barranquilla, Colombia, 80020
    • Not yet recruiting
    • Clínica de la Costa S.A.S
  • Bogota, Colombia, 110221
    • Not yet recruiting
    • Administradora Country S.A.
  • Bogota, Colombia, 111511
    • Not yet recruiting
    • Instituto Nacional De Cancerologia
  • Monteria, Colombia, 230001
    • Not yet recruiting
    • Oncomedica S.A.
• Croatia
  • Rijeka, Croatia, 51000
    • Recruiting
    • Specialty Hospital Medico
  • Zagreb, Croatia, 10000
    • Recruiting
    • University Hospital Centre Sestre Milosrdnice
• Finland
  • Helsinki, Finland, 00029
    • Not yet recruiting
    • Helsinki University Central Hospital
• France
  • Bobigny Cedex, France, 93000
    • Recruiting
    • Avicenne Hospital
  • Bordeaux, France, 33075
    • Recruiting
    • Bordeaux Chu Hopital Saint - Andre
  • Boulogne-billancourt, France, 92100
    • Recruiting
    • Hospital Ambroise Pare
  • Clermont Ferrand Cedex 1, France, 63003
    • Recruiting
    • Chu de Clermont - Ferrand- Hospital Estaing
  • Dijon, France, 21079
    • Recruiting
    • CHU Dijon - Hopital Francois Mitterrand
  • Dijon Cedex, France, 21079
    • Recruiting
    • Centre Georges Francois Leclerc
  • La Tronche, France, 38700
    • Recruiting
    • Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
  • Lille Cedex, France, 59037
    • Recruiting
    • Chru de Lille Hopital Claude Huriez
  • Marseille Cedex 5, France, 13385
    • Recruiting
    • CHU Hôpital de la Timone
  • Nantes, France, 44093
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
  • Nice Cedex 3, France, 06200
    • Recruiting
    • Chu de Nice - Hospital L Archet
  • Paris, France, 75010
    • Recruiting
    • Hospital Saint Louis
  • Pau Cedex, France, 64046
    • Recruiting
    • Centre Hospitalier de Pau - Hopital Francois Mitterrand
  • Pierre Bénite Cedex, France, 69495
    • Recruiting
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Rouen Cedex, France, 76031
    • Recruiting
    • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
  • Saint Etienne Cedex 2, France, 42055
    • Recruiting
    • University Hospital of Saint Etienne
  • Villejuif Cedex, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Hungary
  • Budapest, Hungary, 01085
    • Recruiting
    • Semmelweis Egyetem
  • Pecs, Hungary, 07632
    • Recruiting
    • Pecsi Tudomanyegyetem
  • Szeged, Hungary, 06720
    • Not yet recruiting
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• Korea, Republic of
  • Seongnam-si,, Korea, Republic of, 13496
    • Recruiting
    • CHA Bundang Medical Center
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Mexico
  • Chihuahua, Mexico, 31000
    • Not yet recruiting
    • Centro Estatal de Cancerologia de Chihuahua
  • Ciudad de México, Mexico, 03100
    • Not yet recruiting
    • Health Pharma Professional Research S.A. de C.V.
  • Guadalajara, Mexico, 44280
    • Not yet recruiting
    • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Leon, Mexico, C.P. 37178
    • Not yet recruiting
    • Preparaciones Oncologicas, S.C
  • Merida, Mexico, 97134
    • Not yet recruiting
    • Centro de Atención E Investigación Clínica En Oncología
  • Merida, Mexico, 97125
    • Not yet recruiting
    • Merida - Investigacion Clinica
  • Mexico, Mexico, 06760
    • Not yet recruiting
    • Centro de Investigacion Clinica de Oaxaca
  • Monterrey, Mexico, 64710
    • Not yet recruiting
    • I Can Oncology Center S.A. de C.V.
  • Monterrey, Mexico, 64320
    • Not yet recruiting
    • Joaquin Gabriel Reinoso Toledo
  • Veracruz, Mexico, 91900
    • Not yet recruiting
    • Instituto Veracruzano En Investigacion Clinica S.C
• Montenegro
  • Podgorica, Montenegro, 81000
    • Not yet recruiting
    • Clinical Center of Montenegro
• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Withdrawn
    • Universitair Medisch Centrum Groningen (Umcg)
• New Zealand
  • Hamilton, New Zealand, 03200
    • Recruiting
    • Waikato Hospital
• North Macedonia
  • Skopje, North Macedonia, 01000
    • Recruiting
    • University Clinic For Radiotherapy and Oncology
• Romania
  • Bucuresti, Romania, 30463
    • Not yet recruiting
    • S.C Policlinica Ccbr S.R.L
  • Bucuresti, Romania, 13823
    • Not yet recruiting
    • Spitalul de Oncologie Monza Srl
  • Cluj Napoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Cluj-napoca, Romania, 400641
    • Recruiting
    • Medisprof
  • Craiova, Romania, 200347
    • Recruiting
    • Centrul de Oncologie Sf. Nectarie Craiova
  • Suceava, Romania, 720284
    • Recruiting
    • S.C. Sigmedical Services Srl
  • Timisoara, Romania, 300239
    • Recruiting
    • Oncomed Srl
• South Africa
  • Centurion, South Africa, 01692
    • Recruiting
    • Johese Clinical Research: Midstream
  • Johannesburg, South Africa, 02196
    • Recruiting
    • The Medical Oncology Centre of Rosebank
  • Johannesburg, South Africa, 01864
    • Recruiting
    • Chris Hani Baragwanath Hospital
  • Johannesburg, South Africa, 02193
    • Recruiting
    • WITS Clinical Research
  • Port Elizabeth, South Africa, 06001
    • Recruiting
    • PHOENIX Pharma (Pty) Ltd
  • Pretoria, South Africa, 00084
    • Recruiting
    • University of Pretoria Oncology Department
• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital General Universitario Vall D Hebron
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic Barcelona Main
  • El Palmar, Spain, 30120
    • Recruiting
    • Hospital Universitario Virgen de La Arrixaca
  • L'hospitalet de Llobregat, Spain, 08908
    • Recruiting
    • Ico Institut Catala D Oncologia
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28027
    • Recruiting
    • Clinical Universidad de Navarra Madrid
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Universidad de Navarra (Cun)
  • San Sebastian, Spain, 20014
    • Not yet recruiting
    • Hospital Universitario Donostia
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet
• Turkey
  • Adana, Turkey, 01240
    • Withdrawn
    • Baskent University Adana Application and Research Center
  • Adana, Turkey, 01140
    • Recruiting
    • Medical Park Seyhan Hospital
  • Ankara, Turkey, 06800
    • Not yet recruiting
    • Ankara City Hospital
  • Edirne, Turkey, 22030
    • Not yet recruiting
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34098
    • Not yet recruiting
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
• United States
  • California
    • La Jolla, California, United States, 92122
      • Not yet recruiting
      • Scripps Green Hospital
    • Los Angeles, California, United States, 90067
      • Not yet recruiting
      • Valkyrie Clinical Trials
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • University of Michigan
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • University of Texas M. D. Anderson Cancer Center

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

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 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): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

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 by Histologic Type; Neoplasms; 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