A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

Trial Title: A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

NCT ID: NCT05888844

Condition: Cutaneous Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell

Conditions: Keywords:
Cutaneous Squamous Cell Carcinoma
Anti-PD-L1 antibody
Metastatic cutaneous squamous cell carcinoma
Locally advanced cutaneous squamous cell carcinoma

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: INCB099280
Description: Administered as specified in the treatment arm description.
Arm group label: Part 1: INCB099280 Dose 1
Arm group label: Part 1: INCB099280 Dose 2
Arm group label: Part 1: INCB099280 Dose 3
Arm group label: Part 2: INCB099280 Dose selected from Part 1

Summary: This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Border Medical Oncology Research Unit

Address:
City: Albury
Zip: 02640
Country: Australia

Facility:
Name: Townsville Cancer Centre

Address:
City: Townsville
Zip: 04814
Country: Australia

Facility:
Name: Princess Alexandra Hospital Australia

Address:
City: Woolloongabba
Zip: 04102
Country: Australia

Facility:
Name: Box Hill Hospital

Address:
City: Box Hill
Zip: 03128
Country: Australia

Facility:
Name: Monash Medical Centre Clayton

Address:
City: Clayton
Zip: 03168
Country: Australia

Facility:
Name: Fundacao Pio Xii Hospital de Cancer de Barretos

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Facility:
Name: Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina

Address:
City: Florianópolis
Zip: 88034-000
Country: Brazil

Facility:
Name: Oncosite - Centro de Pesquisa Clinica E Oncologia

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Fundacao Doutor Amaral Carvalho

Address:
City: JAÚ
Zip: 17210-120
Country: Brazil

Facility:
Name: Hospital Sao Vicente de Paulo

Address:
City: Passo Fundo
Zip: 99010-080
Country: Brazil

Facility:
Name: Irmandade Da Santa Casa de Misericordia de Porto Alegre

Address:
City: Porto Alegre
Zip: 90020-090
Country: Brazil

Facility:
Name: Hgb - Hospital Giovanni Battista - Mae de Deus Center

Address:
City: Porto Alegre
Zip: 90110-270
Country: Brazil

Facility:
Name: Instituto de Oncologia Saint Gallen

Address:
City: Santa Cruz Do Sul
Zip: 96810-110
Country: Brazil

Facility:
Name: Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

Address:
City: Santo André
Zip: 09060-650
Country: Brazil

Facility:
Name: A. C. Camargo Cancer Center

Address:
City: São Paulo
Zip: 01509-900
Country: Brazil

Facility:
Name: Q.E. Ii Health Sciences Centre

Address:
City: Halifax
Zip: B3H 1V7
Country: Canada

Facility:
Name: McGill University Jewish General Hospital

Address:
City: Montreal
Zip: H4A 3J1
Country: Canada

Facility:
Name: Cdiem - Centro de Investigacion Y Especialidades Medicas

Address:
City: Santiago
Zip: 00000
Country: Chile

Facility:
Name: James Lind Centro de Investigacion Del Cancer

Address:
City: Temuco
Zip: 4800827
Country: Chile

Facility:
Name: Clinical Research Chile Spa.

Address:
City: Valdivia
Zip: 5090000
Country: Chile

Facility:
Name: Specialty Hospital Medico

Address:
City: Rijeka
Zip: 51000
Country: Croatia

Facility:
Name: University Hospital Centre Sestre Milosrdnice

Address:
City: Zagreb
Zip: 10000
Country: Croatia

Facility:
Name: Avicenne Hospital

Address:
City: Bobigny Cedex
Zip: 93000
Country: France

Facility:
Name: Bordeaux Chu Hopital Saint - Andre

Address:
City: Bordeaux
Zip: 33075
Country: France

Facility:
Name: Hospital Ambroise Pare

Address:
City: Boulogne-billancourt
Zip: 92100
Country: France

Facility:
Name: Chu de Clermont - Ferrand- Hospital Estaing

Address:
City: Clermont Ferrand Cedex 1
Zip: 63003
Country: France

Facility:
Name: Centre Georges Francois Leclerc

Address:
City: Dijon Cedex
Zip: 21079
Country: France

Facility:
Name: Chu Dijon - Hôpital François Mitterrand

Address:
City: Dijon
Zip: 21079
Country: France

Facility:
Name: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

Address:
City: La Tronche
Zip: 38700
Country: France

Facility:
Name: Chru de Lille Hopital Claude Huriez

Address:
City: Lille Cedex
Zip: 59037
Country: France

Facility:
Name: Chu Hopital de La Timone

Address:
City: Marseille Cedex 5
Zip: 13385
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

Address:
City: Nantes
Zip: 44093
Country: France

Facility:
Name: Chu de Nice - Hospital L Archet

Address:
City: Nice Cedex 3
Zip: 06200
Country: France

Facility:
Name: Hospital Saint Louis

Address:
City: Paris
Zip: 75010
Country: France

Facility:
Name: Centre Hospitalier de Pau - Hôpital François Mitterrand

Address:
City: Pau Cedex
Zip: 64046
Country: France

Facility:
Name: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Address:
City: Pierre Bénite Cedex
Zip: 69495
Country: France

Facility:
Name: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

Address:
City: Rouen Cedex
Zip: 76031
Country: France

Facility:
Name: University Hospital of Saint Etienne

Address:
City: Saint Etienne Cedex 2
Zip: 42055
Country: France

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif Cedex
Zip: 94805
Country: France

Facility:
Name: Semmelweis Egyetem

Address:
City: Budapest
Zip: 01085
Country: Hungary

Facility:
Name: Pecsi Tudomanyegyetem

Address:
City: Pecs
Zip: 07632
Country: Hungary

Facility:
Name: Cha Bundang Medical Center

Address:
City: Seongnam-si,
Zip: 13496
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Clinical Center of Montenegro

Address:
City: Podgorica
Zip: 81000
Country: Montenegro

Facility:
Name: Waikato Hospital

Address:
City: Hamilton
Zip: 03200
Country: New Zealand

Facility:
Name: University Clinic For Radiotherapy and Oncology

Address:
City: Skopje
Zip: 01000
Country: North Macedonia

Facility:
Name: S.C Policlinica Ccbr S.R.L

Address:
City: Bucuresti
Zip: 30463
Country: Romania

Facility:
Name: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Address:
City: Cluj Napoca
Zip: 400015
Country: Romania

Facility:
Name: Medisprof

Address:
City: Cluj-napoca
Zip: 400641
Country: Romania

Facility:
Name: Centrul de Oncologie Sf. Nectarie Craiova

Address:
City: Craiova
Zip: 200347
Country: Romania

Facility:
Name: S.C. Sigmedical Services Srl

Address:
City: Suceava
Zip: 720284
Country: Romania

Facility:
Name: Oncomed Srl

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: Johese Clinical Research: Midstream

Address:
City: Centurion
Zip: 01692
Country: South Africa

Facility:
Name: Chris Hani Baragwanath Hospital

Address:
City: Johannesburg
Zip: 01864
Country: South Africa

Facility:
Name: Wits Clinical Research

Address:
City: Johannesburg
Zip: 02193
Country: South Africa

Facility:
Name: The Medical Oncology Centre of Rosebank

Address:
City: Johannesburg
Zip: 02196
Country: South Africa

Facility:
Name: Phoenix Pharma (Pty) Ltd

Address:
City: Port Elizabeth
Zip: 06001
Country: South Africa

Facility:
Name: University of Pretoria Oncology Department

Address:
City: Pretoria
Zip: 00084
Country: South Africa

Facility:
Name: Germans Trias I Pujol

Address:
City: Badalona
Zip: 08916
Country: Spain

Facility:
Name: Hospital General Universitario Vall D Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Clinic Barcelona Main

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital de La Santa Creu I Sant Pau

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Hospital Universitario Virgen de La Arrixaca

Address:
City: El Palmar
Zip: 30120
Country: Spain

Facility:
Name: Ico Institut Catala D Oncologia

Address:
City: L'hospitalet de Llobregat
Zip: 08906
Country: Spain

Facility:
Name: Hospital General Universitario Gregorio Maranon

Address:
City: Madrid
Zip: 28007
Country: Spain

Facility:
Name: Clinical Universidad de Navarra Madrid

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: Hospital Universitario Ramon Y Cajal

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Regional Universitario de Malaga

Address:
City: Málaga
Zip: 29010
Country: Spain

Facility:
Name: Clinica Universidad de Navarra (Cun)

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hospital Universitario Virgen Macarena

Address:
City: Sevilla
Zip: 41009
Country: Spain

Facility:
Name: Hospital Universitario Miguel Servet

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: Medical Park Seyhan Hospital

Address:
City: Adana
Zip: 01140
Country: Turkey

Facility:
Name: Ankara City Hospital

Address:
City: Ankara
Zip: 06800
Country: Turkey

Facility:
Name: Trakya University Medical Faculty

Address:
City: Edirne
Zip: 22030
Country: Turkey

Start date: October 9, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Incyte Corporation
Agency class: Industry

Source: Incyte Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05888844