Clinical trial NCT05888844: A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
Official title: A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Keywords: Cutaneous Squamous Cell Carcinoma
Anti-PD-L1 antibody
Metastatic cutaneous squamous cell carcinoma
Locally advanced cutaneous squamous cell carcinoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of 2 parts. In Part 1, participants with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC will be randomized 1:1:1 to INCB099280 Dose 1, Dose 2, or Dose 3. In Part 2, one dose level identified from Part 1 will be expanded to enroll additional participants with metastatic cSCC and locally advanced cSCC.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 2 years 3 months
measure: Number of participants with TEAEs leading to dose modification or discontinuation
timeFrame: Up to 2 years
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Duration Of Response (DOR)
timeFrame: Up to 2 years
measure: Time to Response (TTR)
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: INCB099280 pharmacokinetic (PK) in Plasma
timeFrame: 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)
Other outcomes:
Locations:
city: Albury
country: Australia
facility: Border Medical Oncology Research Unit
state: New South Wales
city: Townsville
country: Australia
facility: Townsville Cancer Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Australia
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Barretos
country: Brazil
facility: Fundacao Pio Xii Hospital de Cancer de Barretos
city: Florianópolis
country: Brazil
facility: Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica E Oncologia
city: JAÚ
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hgb - Hospital Giovanni Battista - Mae de Deus Center
city: Santa Cruz Do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen
city: Santo André
country: Brazil
facility: Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
city: Halifax
country: Canada
facility: Q.E. Ii Health Sciences Centre
state: Nova Scotia
city: Montreal
country: Canada
facility: McGill University Jewish General Hospital
state: Quebec
city: Santiago
country: Chile
facility: Cdiem - Centro de Investigacion Y Especialidades Medicas
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion Del Cancer
city: Valdivia
country: Chile
facility: Clinical Research Chile Spa.
city: Rijeka
country: Croatia
facility: Specialty Hospital Medico
city: Zagreb
country: Croatia
facility: University Hospital Centre Sestre Milosrdnice
city: Bobigny Cedex
country: France
facility: Avicenne Hospital
city: Bordeaux
country: France
facility: Bordeaux Chu Hopital Saint - Andre
city: Boulogne-billancourt
country: France
facility: Hospital Ambroise Pare
city: Clermont Ferrand Cedex 1
country: France
facility: Chu de Clermont - Ferrand- Hospital Estaing
city: Dijon Cedex
country: France
facility: Centre Georges Francois Leclerc
city: Dijon
country: France
facility: Chu Dijon - Hôpital François Mitterrand
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
city: Lille Cedex
country: France
facility: Chru de Lille Hopital Claude Huriez
city: Marseille Cedex 5
country: France
facility: Chu Hopital de La Timone
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
city: Nice Cedex 3
country: France
facility: Chu de Nice - Hospital L Archet
city: Paris
country: France
facility: Hospital Saint Louis
city: Pau Cedex
country: France
facility: Centre Hospitalier de Pau - Hôpital François Mitterrand
city: Pierre Bénite Cedex
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud
city: Rouen Cedex
country: France
facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
city: Saint Etienne Cedex 2
country: France
facility: University Hospital of Saint Etienne
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Seongnam-si,
country: Korea, Republic of
facility: Cha Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Podgorica
country: Montenegro
facility: Clinical Center of Montenegro
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Skopje
country: North Macedonia
facility: University Clinic For Radiotherapy and Oncology
city: Bucuresti
country: Romania
facility: S.C Policlinica Ccbr S.R.L
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Cluj-napoca
country: Romania
facility: Medisprof
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie Craiova
city: Suceava
country: Romania
facility: S.C. Sigmedical Services Srl
city: Timisoara
country: Romania
facility: Oncomed Srl
city: Centurion
country: South Africa
facility: Johese Clinical Research: Midstream
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma (Pty) Ltd
city: Pretoria
country: South Africa
facility: University of Pretoria Oncology Department
city: Badalona
country: Spain
facility: Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona Main
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
city: L'hospitalet de Llobregat
country: Spain
facility: Ico Institut Catala D Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Clinical Universidad de Navarra Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra (Cun)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Adana
country: Turkey
facility: Medical Park Seyhan Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: