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

Cutaneous Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888844
• Other study ID #: INCB 99280-212
• Secondary ID: 2022-502476-23-0
• Status: Recruiting
• Phase: Phase 2
• Start date: October 9, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma

Intervention

Drug:
• INCB099280
Administered as specified in the treatment arm description.

Locations

Country	Name	City	State
Australia	Border Medical Oncology Research Unit	Albury	New South Wales
Australia	Bendigo Hospital	Bendigo	Victoria
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Monash Medical Centre Clayton	Clayton	Victoria
Australia	Townsville Cancer Centre	Townsville	Queensland
Australia	Princess Alexandra Hospital Australia	Woolloongabba	Queensland
Brazil	Fundacao Pio Xii Hospital de Cancer de Barretos	Barretos
Brazil	Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina	Florianópolis
Brazil	Oncosite - Centro de Pesquisa Clinica E Oncologia	Ijui
Brazil	Fundacao Doutor Amaral Carvalho	JAÚ
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo
Brazil	Hgb - Hospital Giovanni Battista - Mae de Deus Center	Porto Alegre
Brazil	Irmandade Da Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Instituto de Oncologia Saint Gallen	Santa Cruz Do Sul
Brazil	Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia	Santo André
Brazil	A. C. Camargo Cancer Center	São Paulo
Canada	Q.E. Ii Health Sciences Centre	Halifax	Nova Scotia
Canada	McGill University Jewish General Hospital	Montreal	Quebec
Chile	Cdiem - Centro de Investigacion Y Especialidades Medicas	Santiago
Chile	James Lind Centro de Investigacion Del Cancer	Temuco
Chile	Clinical Research Chile Spa.	Valdivia
Croatia	Specialty Hospital Medico	Rijeka
Croatia	University Hospital Centre Sestre Milosrdnice	Zagreb
France	Avicenne Hospital	Bobigny Cedex
France	Bordeaux Chu Hopital Saint - Andre	Bordeaux
France	Hospital Ambroise Pare	Boulogne-billancourt
France	Chu de Clermont - Ferrand- Hospital Estaing	Clermont Ferrand Cedex 1
France	Chu Dijon - Hôpital François Mitterrand	Dijon
France	Centre Georges Francois Leclerc	Dijon Cedex
France	Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon	La Tronche
France	Chru de Lille Hopital Claude Huriez	Lille Cedex
France	Chu Hopital de La Timone	Marseille Cedex 5
France	Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu	Nantes
France	Chu de Nice - Hospital L Archet	Nice Cedex 3
France	Hospital Saint Louis	Paris
France	Centre Hospitalier de Pau - Hôpital François Mitterrand	Pau Cedex
France	Hospices Civils de Lyon Centre Hospitalier Lyon Sud	Pierre Bénite Cedex
France	Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume	Rouen Cedex
France	University Hospital of Saint Etienne	Saint Etienne Cedex 2
France	Institut Gustave Roussy	Villejuif Cedex
Hungary	Semmelweis Egyetem	Budapest
Hungary	Pecsi Tudomanyegyetem	Pecs
Korea, Republic of	Cha Bundang Medical Center	Seongnam-si,
Korea, Republic of	Asan Medical Center	Seoul
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
Netherlands	Universitair Medisch Centrum Groningen (Umcg)	Groningen
New Zealand	Waikato Hospital	Hamilton
North Macedonia	University Clinic For Radiotherapy and Oncology	Skopje
Romania	S.C Policlinica Ccbr S.R.L	Bucuresti
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca
Romania	Medisprof	Cluj-napoca
Romania	Centrul de Oncologie Sf. Nectarie Craiova	Craiova
Romania	S.C. Sigmedical Services Srl	Suceava
Romania	Oncomed Srl	Timisoara
South Africa	Johese Clinical Research: Midstream	Centurion
South Africa	Chris Hani Baragwanath Hospital	Johannesburg
South Africa	The Medical Oncology Centre of Rosebank	Johannesburg
South Africa	Wits Clinical Research	Johannesburg
South Africa	Phoenix Pharma (Pty) Ltd	Port Elizabeth
South Africa	University of Pretoria Oncology Department	Pretoria
Spain	Germans Trias I Pujol	Badalona
Spain	Hospital Clinic Barcelona Main	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital General Universitario Vall D Hebron	Barcelona
Spain	Hospital Universitario Virgen de La Arrixaca	El Palmar
Spain	Ico Institut Catala D Oncologia	L'hospitalet de Llobregat
Spain	Clinical Universidad de Navarra Madrid	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Regional Universitario de Malaga	Málaga
Spain	Clinica Universidad de Navarra (Cun)	Pamplona
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
Turkey	Baskent University Adana Application and Research Center	Adana
Turkey	Medical Park Seyhan Hospital	Adana
Turkey	Trakya University Medical Faculty	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

Australia,  Brazil,  Canada,  Chile,  Croatia,  France,  Hungary,  Korea, Republic of,  Netherlands,  New Zealand,  North Macedonia,  Romania,  South Africa,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	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.	Up to 2 years
Primary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	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.	Up to 2 years 3 months
Primary	Number of participants with TEAEs leading to dose modification or discontinuation	Number of participants with TEAEs leading to dose modification or discontinuation.	Up to 2 years
Secondary	Disease Control Rate (DCR)	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.	Up to 2 years
Secondary	Duration Of Response (DOR)	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.	Up to 2 years
Secondary	Time to Response (TTR)	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.	Up to 2 years
Secondary	Progression-free survival (PFS)	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.	Up to 2 years
Secondary	Overall Survival (OS)	Defined as the time from the date of first dose to death due to any cause.	Up to 2 years
Secondary	INCB099280 pharmacokinetic (PK) in Plasma	INCB099280 concentration 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)