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)
Objective response rate (ORR) — Up to 2 years 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.
Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to 2 years 3 months 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.
Number of participants with TEAEs leading to dose modification or discontinuation — Up to 2 years Number of participants with TEAEs leading to dose modification or discontinuation.
Trial sites (77)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.