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

Primary Purpose

Cutaneous Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB099280
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring Cutaneous Squamous Cell Carcinoma, Anti-PD-L1 antibody, Metastatic cutaneous squamous cell carcinoma, Locally advanced cutaneous squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Border Medical Oncology Research UnitRecruiting
  • Townsville Cancer Centre
  • Princess Alexandra Hospital Australia
  • Box Hill Hospital
  • Monash Medical Centre Clayton
  • Fundacao Pio Xii Hospital de Cancer de Barretos
  • Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
  • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • Fundacao Doutor Amaral Carvalho
  • Hospital Sao Vicente de Paulo
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre
  • Hospital de Clinicas de Porto Alegre
  • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Hospital Nossa Senhora Da Conceicao
  • Nob - Nucleo de Oncologia Da Bahia
  • Instituto de Oncologia Saint Gallen
  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  • Instituto Do Cancer de Sao Paulo - Icesp
  • A. C. Camargo Cancer Center
  • Q.E. Ii Health Sciences Centre
  • Toronto Sunnybrook Hospital
  • Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
  • McGill University Jewish General Hospital
  • Cdiem - Centro de Investigacion Y Especialidades Medicas
  • Centro de Investigacion Clinica Bradford Hill
  • James Lind Centro de Investigacion Del Cancer
  • Clinical Research Chile Spa.
  • Clínica de La Costa S.A.S
  • Administradora Country S.A.
  • Instituto Nacional de Cancerologia
  • Oncomedica S.A.
  • Special Hospital Medico
  • University Hospital Centre Sestre Milosrdnice
  • Helsinki University Central Hospital
  • Avicenne Hospital
  • Bordeaux Chu Hopital Saint - Andre
  • Hospital Ambroise Pare
  • Chu de Clermont - Ferrand- Hospital Estaing
  • Centre Georges Francois Leclerc
  • Chu Dijon - Hopital Du Bocage
  • Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
  • Chru de Lille Hopital Claude Huriez
  • Chu Hopital de La Timone
  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Chu de Nice - Hospital L Archet
  • Hospital Saint Louis
  • Centre Hospitalier de Pau - Hôpital François Mitterrand
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Centre Eugene Marquis
  • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
  • University Hospital of Saint Etienne
  • Institut Gustave Roussy
  • Semmelweis Egyetem
  • Pecsi Tudomanyegyetem
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Cha Bundang Medical Center
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Centro Estatal de Cancerologia de Chihuahua
  • Health Pharma Professional Research S.A. de C.V.
  • Hospital Civil Fray Antonio Alcalde
  • Preparaciones Oncologicas, S.C
  • Merida - Investigacion Clinica
  • Centro de Atención E Investigación Clínica En Oncología
  • Centro de Investigacion Clinica de Oaxaca
  • Consultorio Del Dr. Joaquin Gabriel Reinoso Toledo
  • I Can Oncology Center S.A. de C.V.
  • Instituto Veracruzano En Investigacion Clinica S.C
  • Clinical Center of Montenegro
  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
  • Waikato HospitalRecruiting
  • University Clinic For Radiotherapy and Oncology
  • S.C. Focus Lab Plus Srl
  • S.C Policlinica Ccbr S.R.L
  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Medisprof
  • Centrul de Oncologie Sf. Nectarie Craiova
  • S.C. Sigmedical Services Srl
  • Oncomed Srl
  • Johese Clinical Research: Midstream
  • Chris Hani Baragwanath Hospital
  • Wits Clinical Research
  • The Medical Oncology Centre of Rosebank
  • Phoenix Pharma (Pty) Ltd
  • University of Pretoria Oncology Department
  • Ico Hospital Germans Trias I Pujol
  • Hospital General Universitario Vall D Hebron
  • Hospital Clinic Barcelona Main
  • Hospital de La Santa Creu I Sant Pau
  • Ico Institut Catala D Oncologia
  • Hospital Universitario Virgen de La Arrixaca
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon Y Cajal
  • Hospital Regional Universitario de Malaga
  • Clinica Universidad de Navarra (Cun)
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Miguel Servet
  • Medical Park Seyhan Hospital
  • Baskent University Adana Application and Research Center
  • Ankara City Hospital
  • Trakya University Medical Faculty
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1: INCB099280 Dose 1

Part 1: INCB099280 Dose 2

Part 1: INCB099280 Dose 3

Part 2: INCB099280 Dose selected from Part 1

Arm Description

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Outcomes

Primary Outcome Measures

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.
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.
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.

Secondary Outcome Measures

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.
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.
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.
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.
Overall Survival (OS)
Defined as the time from the date of first dose to death due to any cause.
INCB099280 pharmacokinetic (PK) in Plasma
INCB099280 concentration in plasma

Full Information

First Posted
May 24, 2023
Last Updated
September 20, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05888844
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Squamous Cell Carcinoma
Keywords
Cutaneous Squamous Cell Carcinoma, Anti-PD-L1 antibody, Metastatic cutaneous squamous cell carcinoma, Locally advanced cutaneous squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: INCB099280 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
Arm Title
Part 1: INCB099280 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
Arm Title
Part 1: INCB099280 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
Arm Title
Part 2: INCB099280 Dose selected from Part 1
Arm Type
Experimental
Arm Description
Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
Intervention Type
Drug
Intervention Name(s)
INCB099280
Intervention Description
Administered as specified in the treatment arm description.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
Up to 2 years
Title
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 2 years 3 months
Title
Number of participants with TEAEs leading to dose modification or discontinuation
Description
Number of participants with TEAEs leading to dose modification or discontinuation.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Up to 2 years
Title
Duration Of Response (DOR)
Description
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 Frame
Up to 2 years
Title
Time to Response (TTR)
Description
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.
Time Frame
Up to 2 years
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to 2 years
Title
Overall Survival (OS)
Description
Defined as the time from the date of first dose to death due to any cause.
Time Frame
Up to 2 years
Title
INCB099280 pharmacokinetic (PK) in Plasma
Description
INCB099280 concentration in plasma
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
02640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Townsville Cancer Centre
City
Townsville
State/Province
Queensland
ZIP/Postal Code
04814
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Princess Alexandra Hospital Australia
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
04102
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
03128
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Monash Medical Centre Clayton
City
Clayton
State/Province
Victoria
ZIP/Postal Code
03168
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Fundacao Pio Xii Hospital de Cancer de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Oncosite - Centro de Pesquisa Clinica E Oncologia
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Fundacao Doutor Amaral Carvalho
City
JAÚ
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Irmandade Da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hgb - Hospital Giovanni Battista - Mae de Deus Center
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Nossa Senhora Da Conceicao
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Nob - Nucleo de Oncologia Da Bahia
City
Salvador
ZIP/Postal Code
40170110
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Oncologia Saint Gallen
City
Santa Cruz Do Sul
ZIP/Postal Code
96810-110
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
City
Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto Do Cancer de Sao Paulo - Icesp
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
A. C. Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Q.E. Ii Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Toronto Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
McGill University Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Cdiem - Centro de Investigacion Y Especialidades Medicas
City
Santiago
ZIP/Postal Code
00000
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigacion Clinica Bradford Hill
City
Santiago
ZIP/Postal Code
13127
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
James Lind Centro de Investigacion Del Cancer
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Chile Spa.
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Clínica de La Costa S.A.S
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Administradora Country S.A.
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Instituto Nacional de Cancerologia
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Special Hospital Medico
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Centre Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Avicenne Hospital
City
Bobigny Cedex
ZIP/Postal Code
93000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Bordeaux Chu Hopital Saint - Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hospital Ambroise Pare
City
Boulogne-billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu de Clermont - Ferrand- Hospital Estaing
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Georges Francois Leclerc
City
Dijon Cedex
ZIP/Postal Code
21034
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu Dijon - Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chru de Lille Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu Hopital de La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Chu de Nice - Hospital L Archet
City
Nice Cedex 3
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hospital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier de Pau - Hôpital François Mitterrand
City
Pau Cedex
ZIP/Postal Code
64046
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Eugene Marquis
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Not yet recruiting
Facility Name
University Hospital of Saint Etienne
City
Saint Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
01085
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
07632
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
06720
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Cha Bundang Medical Center
City
Seongnam-si,
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Centro Estatal de Cancerologia de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Health Pharma Professional Research S.A. de C.V.
City
Ciudad de México
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Preparaciones Oncologicas, S.C
City
Leon
ZIP/Postal Code
C.P. 37178
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Merida - Investigacion Clinica
City
Merida
ZIP/Postal Code
97125
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Centro de Atención E Investigación Clínica En Oncología
City
Merida
ZIP/Postal Code
97134
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Mexico
ZIP/Postal Code
06760
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Consultorio Del Dr. Joaquin Gabriel Reinoso Toledo
City
Monterrey
ZIP/Postal Code
64320
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
I Can Oncology Center S.A. de C.V.
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Instituto Veracruzano En Investigacion Clinica S.C
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center of Montenegro
City
Podgorica
ZIP/Postal Code
81000
Country
Montenegro
Individual Site Status
Not yet recruiting
Facility Name
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
03200
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
University Clinic For Radiotherapy and Oncology
City
Skopje
ZIP/Postal Code
01000
Country
North Macedonia
Individual Site Status
Not yet recruiting
Facility Name
S.C. Focus Lab Plus Srl
City
Bucuresti
ZIP/Postal Code
22548
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
S.C Policlinica Ccbr S.R.L
City
Bucuresti
ZIP/Postal Code
30463
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Medisprof
City
Cluj-napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Centrul de Oncologie Sf. Nectarie Craiova
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
S.C. Sigmedical Services Srl
City
Suceava
ZIP/Postal Code
720284
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Oncomed Srl
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Johese Clinical Research: Midstream
City
Centurion
ZIP/Postal Code
01692
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Chris Hani Baragwanath Hospital
City
Johannesburg
ZIP/Postal Code
01864
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Wits Clinical Research
City
Johannesburg
ZIP/Postal Code
02193
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
The Medical Oncology Centre of Rosebank
City
Johannesburg
ZIP/Postal Code
02196
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Phoenix Pharma (Pty) Ltd
City
Port Elizabeth
ZIP/Postal Code
06001
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
University of Pretoria Oncology Department
City
Pretoria
ZIP/Postal Code
00002
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Ico Hospital Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinic Barcelona Main
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Ico Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Clinica Universidad de Navarra (Cun)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Medical Park Seyhan Hospital
City
Adana
ZIP/Postal Code
01140
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Baskent University Adana Application and Research Center
City
Adana
ZIP/Postal Code
01240
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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