Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
Protocole ID	INCB 99280-212
ClinicalTrials.gov ID	NCT05888844
Type(s) de cancer	Peau
Phase	Phase II
Type étude	Clinique
Médicament	INCB099280
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville	Montréal
Investigateur(trice) principal(e)	Dr à venir
Coordonnateur(trice)
Statut	Actif en recrutement
Date d'activation	31-05-2024
Critètes d'éligibilité	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.
Critètes d'exclusion	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.

Groupe d'étude en oncologie du Québec