A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT05888844
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 63
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: INCB099280 Dose selected from Part 1 INCB099280 Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years. Part 1: INCB099280 Dose 1 INCB099280 Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years. Part 1: INCB099280 Dose 2 INCB099280 Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. Part 1: INCB099280 Dose 3 INCB099280 Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
- Primary Outcome Measures
Name Time Method 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 TEAEs leading to dose modification or discontinuation Up to 2 years Number of participants with TEAEs leading to dose modification or discontinuation.
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.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Up to 2 years Defined as the time from the date of first dose to the earliest date of disease progression as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
INCB099280 pharmacokinetic (PK) in Plasma Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days) INCB099280 concentration in plasma
Disease Control Rate (DCR) Up to 2 years Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment as determined by the BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
Duration Of Response (DOR) Up to 2 years Defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression, as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
Time to Response (TTR) Up to 2 years Defined as the time from the date of first dose to the earliest date of confirmed CR or PR as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
Overall Survival (OS) Up to 2 years Defined as the time from the date of first dose to death due to any cause.
Trial Locations
- Locations (77)
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
🇫🇷Rouen Cedex, France
Centre Hospitalier de Pau - Hôpital François Mitterrand
🇫🇷Pau Cedex, France
University Hospital of Saint Etienne
🇫🇷Saint Etienne Cedex 2, France
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Pecsi Tudomanyegyetem
🇭🇺Pecs, Hungary
Cha Bundang Medical Center
🇰🇷Seongnam-si,, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Waikato Hospital
🇳🇿Hamilton, New Zealand
University Clinic For Radiotherapy and Oncology
🇲🇰Skopje, North Macedonia
S.C Policlinica Ccbr S.R.L
🇷🇴Bucuresti, Romania
Medisprof
🇷🇴Cluj-napoca, Romania
Centrul de Oncologie Sf. Nectarie Craiova
🇷🇴Craiova, Romania
Oncomed Srl
🇷🇴Timisoara, Romania
Johese Clinical Research: Midstream
🇿🇦Centurion, South Africa
Chris Hani Baragwanath Hospital
🇿🇦Johannesburg, South Africa
Wits Clinical Research
🇿🇦Johannesburg, South Africa
The Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, South Africa
Phoenix Pharma (Pty) Ltd
🇿🇦Port Elizabeth, South Africa
University of Pretoria Oncology Department
🇿🇦Pretoria, South Africa
Germans Trias I Pujol
🇪🇸Badalona, Spain
Hospital General Universitario Vall D Hebron
🇪🇸Barcelona, Spain
Hospital Clinic Barcelona Main
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de La Arrixaca
🇪🇸El Palmar, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Medical Park Seyhan Hospital
🇹🇷Adana, Turkey
Ankara City Hospital
🇹🇷Ankara, Turkey
Trakya University Medical Faculty
🇹🇷Edirne, Turkey
Chru de Lille Hopital Claude Huriez
🇫🇷Lille Cedex, France
Chu de Nice - Hospital L Archet
🇫🇷Nice Cedex 3, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, France
Border Medical Oncology Research Unit
🇦🇺Albury, New South Wales, Australia
Townsville Cancer Centre
🇦🇺Townsville, Queensland, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Princess Alexandra Hospital Australia
🇦🇺Woolloongabba, Queensland, Australia
Monash Medical Centre Clayton
🇦🇺Clayton, Victoria, Australia
Fundacao Pio Xii Hospital de Cancer de Barretos
🇧🇷Barretos, Brazil
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
🇧🇷Florianópolis, Brazil
Fundacao Doutor Amaral Carvalho
🇧🇷JAÚ, Brazil
Hospital Sao Vicente de Paulo
🇧🇷Passo Fundo, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
🇧🇷Ijui, Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
🇧🇷Porto Alegre, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
🇧🇷Santo André, Brazil
A. C. Camargo Cancer Center
🇧🇷São Paulo, Brazil
Instituto de Oncologia Saint Gallen
🇧🇷Santa Cruz Do Sul, Brazil
Cdiem - Centro de Investigacion Y Especialidades Medicas
🇨🇱Santiago, Chile
James Lind Centro de Investigacion Del Cancer
🇨🇱Temuco, Chile
Avicenne Hospital
🇫🇷Bobigny Cedex, France
Specialty Hospital Medico
🇭🇷Rijeka, Croatia
Bordeaux Chu Hopital Saint - Andre
🇫🇷Bordeaux, France
Hospital Ambroise Pare
🇫🇷Boulogne-billancourt, France
Centre Georges Francois Leclerc
🇫🇷Dijon Cedex, France
Chu de Clermont - Ferrand- Hospital Estaing
🇫🇷Clermont Ferrand Cedex 1, France
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
🇫🇷La Tronche, France
Chu Dijon - Hôpital François Mitterrand
🇫🇷Dijon, France
Chu Hopital de La Timone
🇫🇷Marseille Cedex 5, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
🇫🇷Nantes, France
Hospital Saint Louis
🇫🇷Paris, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Clinical Center of Montenegro
🇲🇪Podgorica, Montenegro
S.C. Sigmedical Services Srl
🇷🇴Suceava, Romania
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Ico Institut Catala D Oncologia
🇪🇸L'hospitalet de Llobregat, Spain
Clinical Universidad de Navarra Madrid
🇪🇸Madrid, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Clinica Universidad de Navarra (Cun)
🇪🇸Pamplona, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
McGill University Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Clinical Research Chile Spa.
🇨🇱Valdivia, Chile
University Hospital Centre Sestre Milosrdnice
🇭🇷Zagreb, Croatia
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
🇷🇴Cluj Napoca, Romania
Q.E. Ii Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada