Informations générales (source: ClinicalTrials.gov)
A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
Interventional
Phase 2
Incyte Corporation (Voir sur ClinicalTrials)
octobre 2023
décembre 2026
04 juillet 2025
This study is being conducted to determine the safety, tolerability, and preliminary
efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 25/05/2024 16:44:44 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Ambroise Paré | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bordeaux Chu Hopital Saint - Andre - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - 21079 - Dijon Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Pau - Hôpital François Mitterrand - 64046 - Pau Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Chru de Lille Hopital Claude Huriez - 59037 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| Chu de Clermont - Ferrand- Hospital Estaing - 63003 - Clermont Ferrand Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Chu de Nice - Hospital L Archet - 06200 - Nice Cedex 3 - France | Contact (sur clinicalTrials) | ||||
| Chu Dijon - Hôpital François Mitterrand - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Chu Hopital de La Timone - 13385 - Marseille Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume - 76031 - Rouen Cedex - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud - 69495 - Pierre Bénite Cedex - France | Contact (sur clinicalTrials) | ||||
| Hospital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Saint Etienne - 42055 - Saint Etienne Cedex 2 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.