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
2 other identifiers
interventional
63
15 countries
77
Brief Summary
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2023
Typical duration for phase_2
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 28, 2026
February 24, 2026
February 1, 2026
3 years
May 24, 2023
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Secondary Outcomes (6)
Disease Control Rate (DCR)
Up to 2 years
Duration Of Response (DOR)
Up to 2 years
Time to Response (TTR)
Up to 2 years
Progression-free survival (PFS)
Up to 2 years
Overall Survival (OS)
Up to 2 years
- +1 more secondary outcomes
Study Arms (4)
Part 1: INCB099280 Dose 1
EXPERIMENTALParticipants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
Part 1: INCB099280 Dose 2
EXPERIMENTALParticipants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
Part 1: INCB099280 Dose 3
EXPERIMENTALParticipants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
Part 2: INCB099280 Dose selected from Part 1
EXPERIMENTALParticipants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
Interventions
Administered as specified in the treatment arm description.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Border Medical Oncology Research Unit
Albury, New South Wales, 02640, Australia
Townsville Cancer Centre
Townsville, Queensland, 04814, Australia
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102, Australia
Box Hill Hospital
Box Hill, Victoria, 03128, Australia
Monash Medical Centre Clayton
Clayton, Victoria, 03168, Australia
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, 14784-400, Brazil
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
Florianópolis, 88034-000, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, 98700-000, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210-120, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, 90110-270, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, 96810-110, Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-650, Brazil
A. C. Camargo Cancer Center
São Paulo, 01509-900, Brazil
Q.E. Ii Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
McGill University Jewish General Hospital
Montreal, Quebec, H4A 3J1, Canada
Cdiem - Centro de Investigacion Y Especialidades Medicas
Santiago, 00000, Chile
James Lind Centro de Investigacion Del Cancer
Temuco, 4800827, Chile
Clinical Research Chile Spa.
Valdivia, 5090000, Chile
Specialty Hospital Medico
Rijeka, 51000, Croatia
University Hospital Centre Sestre Milosrdnice
Zagreb, 10000, Croatia
Avicenne Hospital
Bobigny, 93000, France
Bordeaux Chu Hopital Saint - Andre
Bordeaux, 33075, France
Hospital Ambroise Pare
Boulogne-Billancourt, 92100, France
Chu de Clermont - Ferrand- Hospital Estaing
Clermont-Ferrand, 63003, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Chu Dijon - Hôpital François Mitterrand
Dijon, 21079, France
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
La Tronche, 38700, France
Chru de Lille Hopital Claude Huriez
Lille, 59037, France
Chu Hopital de La Timone
Marseille, 13385, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, 44093, France
Chu de Nice - Hospital L Archet
Nice, 06200, France
Hospital Saint Louis
Paris, 75010, France
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, 64046, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, 76031, France
University Hospital of Saint Etienne
Saint-Etienne, 42055, France
Institut Gustave Roussy
Villejuif, 94805, France
Semmelweis Egyetem
Budapest, 01085, Hungary
Pecsi Tudomanyegyetem
Pécs, 07632, Hungary
Clinical Center of Montenegro
Podgorica, 81000, Montenegro
Waikato Hospital
Hamilton, 03200, New Zealand
University Clinic For Radiotherapy and Oncology
Skopje, 01000, North Macedonia
S.C Policlinica Ccbr S.R.L
Bucharest, 30463, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Medisprof
Cluj-Napoca, 400641, Romania
Centrul de Oncologie Sf. Nectarie Craiova
Craiova, 200347, Romania
S.C. Sigmedical Services Srl
Suceava, 720284, Romania
Oncomed Srl
Timișoara, 300239, Romania
Johese Clinical Research: Midstream
Centurion, 01692, South Africa
Chris Hani Baragwanath Hospital
Johannesburg, 01864, South Africa
Wits Clinical Research
Johannesburg, 02193, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, 02196, South Africa
Phoenix Pharma (Pty) Ltd
Port Elizabeth, 06001, South Africa
University of Pretoria Oncology Department
Pretoria, 00084, South Africa
Cha Bundang Medical Center
Seongnam-si, 13496, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Germans Trias I Pujol
Badalona, 08916, Spain
Hospital General Universitario Vall D Hebron
Barcelona, 08035, Spain
Hospital Clinic Barcelona Main
Barcelona, 08036, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, 30120, Spain
Ico Institut Catala D Oncologia
L'Hospitalet de Llobregat, 08906, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Clinical Universidad de Navarra Madrid
Madrid, 28027, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Clinica Universidad de Navarra (Cun)
Pamplona, 31008, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Medical Park Seyhan Hospital
Adana, 01140, Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Related Links
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
June 5, 2023
Study Start
October 9, 2023
Primary Completion (Estimated)
September 28, 2026
Study Completion (Estimated)
September 28, 2026
Last Updated
February 24, 2026
Record last verified: 2026-02
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.
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