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Clinical Trials in Canada / NCT05888844
Active, not recruiting Phase 2

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

NCT05888844 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2023-10-09
Last updated
2026-08-17

Condition(s) studied

Cutaneous Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

INCB099280 →

INCB099280: Administered as specified in the treatment arm description.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (77)

FacilityCityRegionStatus
Border Medical Oncology Research Unit Albury New South Wales
Townsville Cancer Centre Townsville Queensland
Princess Alexandra Hospital Australia Woolloongabba Queensland
Box Hill Hospital Box Hill Victoria
Monash Medical Centre Clayton Clayton Victoria
Fundacao Pio Xii Hospital de Cancer de Barretos Barretos Brazil
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina Florianópolis Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia Ijuí Brazil
Fundacao Doutor Amaral Carvalho Jaú Brazil
Hospital Sao Vicente de Paulo Passo Fundo Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center Porto Alegre Brazil
Instituto de Oncologia Saint Gallen Santa Cruz do Sul Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia Santo André Brazil
A. C. Camargo Cancer Center São Paulo Brazil
Q.E. Ii Health Sciences Centre Halifax Nova Scotia
McGill University Jewish General Hospital Montreal Quebec
Cdiem - Centro de Investigacion Y Especialidades Medicas Santiago Chile
James Lind Centro de Investigacion Del Cancer Temuco Chile
Clinical Research Chile Spa. Valdivia Chile
Specialty Hospital Medico Rijeka Croatia
University Hospital Centre Sestre Milosrdnice Zagreb Croatia
Avicenne Hospital Bobigny France
Bordeaux Chu Hopital Saint - Andre Bordeaux France
Hospital Ambroise Pare Boulogne-Billancourt France
Chu de Clermont - Ferrand- Hospital Estaing Clermont-Ferrand France
Centre Georges Francois Leclerc Dijon France
Chu Dijon - Hôpital François Mitterrand Dijon France
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon La Tronche France
Chru de Lille Hopital Claude Huriez Lille France
Chu Hopital de La Timone Marseille France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu Nantes France
Chu de Nice - Hospital L Archet Nice France
Hospital Saint Louis Paris France
Centre Hospitalier de Pau - Hôpital François Mitterrand Pau France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud Pierre-Bénite France
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume Rouen France
University Hospital of Saint Etienne Saint-Etienne France
Institut Gustave Roussy Villejuif France
Semmelweis Egyetem Budapest Hungary

+ 37 more sites — see the full list on the official registry below.

More Incyte Corporation trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05888844 on ClinicalTrials.gov ↗ ← All trials in Canada