Cutaneous Squamous Cell CarcinomaPhase 2NCT05888844
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing INCB099280 in people with Cutaneous Squamous Cell Carcinoma, run by Incyte Corporation at 77 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- INCB099280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 77 sitesin 15 countries
- Study dates
- 9 Oct 2023to 28 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
77 sites in 15 countries.
77 sites in 15 countries
France17 sites
Avicenne Hospital
Bobigny, 93000
Bordeaux Chu Hopital Saint - Andre
Bordeaux, 33075
Hospital Ambroise Pare
Boulogne-Billancourt, 92100
Chu de Clermont - Ferrand- Hospital Estaing
Clermont-Ferrand, 63003
Centre Georges Francois Leclerc
Dijon, 21079
Chu Dijon - Hôpital François Mitterrand
Dijon, 21079
Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon
La Tronche, 38700
Chru de Lille Hopital Claude Huriez
Lille, 59037
Chu Hopital de La Timone
Marseille, 13385
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, 44093
Chu de Nice - Hospital L Archet
Nice, 06200
Hospital Saint Louis
Paris, 75010
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, 64046
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, 76031
University Hospital of Saint Etienne
Saint-Etienne, 42055
Institut Gustave Roussy
Villejuif, 94805
Spain13 sites
Germans Trias I Pujol
Badalona, 08916
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Clinic Barcelona Main
Barcelona, 08036
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
Hospital Universitario Virgen de La Arrixaca
El Palmar, 30120
Ico Institut Catala D Oncologia
L'Hospitalet de Llobregat, 08906
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Clinical Universidad de Navarra Madrid
Madrid, 28027
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Regional Universitario de Malaga
Málaga, 29010
Clinica Universidad de Navarra (Cun)
Pamplona, 31008
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Miguel Servet
Zaragoza, 50009
Brazil10 sites
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, 14784-400
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
Florianópolis, 88034-000
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, 98700-000
Fundacao Doutor Amaral Carvalho
Jaú, 17210-120
Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, 90110-270
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, 96810-110
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-650
A. C. Camargo Cancer Center
São Paulo, 01509-900
Romania6 sites
S.C Policlinica Ccbr S.R.L
Bucharest, 30463
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015
Medisprof
Cluj-Napoca, 400641
Centrul de Oncologie Sf. Nectarie Craiova
Craiova, 200347
S.C. Sigmedical Services Srl
Suceava, 720284
Oncomed Srl
Timișoara, 300239
South Africa6 sites
Johese Clinical Research: Midstream
Centurion, 01692
Chris Hani Baragwanath Hospital
Johannesburg, 01864
Wits Clinical Research
Johannesburg, 02193
The Medical Oncology Centre of Rosebank
Johannesburg, 02196
Phoenix Pharma (Pty) Ltd
Port Elizabeth, 06001
University of Pretoria Oncology Department
Pretoria, 00084
Australia5 sites
Border Medical Oncology Research Unit
Albury, New South Wales, 02640
Box Hill Hospital
Box Hill, Victoria, 03128
Monash Medical Centre Clayton
Clayton, Victoria, 03168
Townsville Cancer Centre
Townsville, Queensland, 04814
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102
South Korea5 sites
Cha Bundang Medical Center
Seongnam-si, 13496
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Chile3 sites
Cdiem - Centro de Investigacion Y Especialidades Medicas
Santiago, 00000
James Lind Centro de Investigacion Del Cancer
Temuco, 4800827
Clinical Research Chile Spa.
Valdivia, 5090000
Turkey (Türkiye)3 sites
Medical Park Seyhan Hospital
Adana, 01140
Ankara City Hospital
Ankara, 06800
Trakya University Medical Faculty
Edirne, 22030
Canada2 sites
Q.E. Ii Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
McGill University Jewish General Hospital
Montreal, Quebec, H4A 3J1
Croatia2 sites
Specialty Hospital Medico
Rijeka, 51000
University Hospital Centre Sestre Milosrdnice
Zagreb, 10000
Hungary2 sites
Semmelweis Egyetem
Budapest, 01085
Pecsi Tudomanyegyetem
Pécs, 07632
North Macedonia1 site
University Clinic For Radiotherapy and Oncology
Skopje, 01000
About this study
Official title: A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- INCB099280
- Keywords
- Cutaneous Squamous Cell Carcinoma, Anti-PD-L1 antibody, Metastatic cutaneous squamous cell carcinoma, Locally advanced cutaneous squamous cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB099280Drug
Administered as specified in the treatment arm description.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: INCB099280 Dose 1 | Experimental | Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
| Part 1: INCB099280 Dose 2 | Experimental | Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
| Part 1: INCB099280 Dose 3 | Experimental | Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
| Part 2: INCB099280 Dose selected from Part 1 | Experimental | Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years 3 months
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Measured: Up to 2 years
Secondary outcomes (6)
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Overall Survival (OS)
Defined as the time from the date of first dose to death due to any cause.
Measured: Up to 2 years
INCB099280 pharmacokinetic (PK) in Plasma
INCB099280 concentration in plasma
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start9 Oct 2023
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888844
- Sponsor's protocol ID
- INCB 99280-212
- Other IDs
- 2022-502476-23-00
- Status last verified
- Oct 2026
- First submitted
- 24 May 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05888844
- Acronym / sponsor ID
- INCB 99280-212
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1: INCB099280 Dose 1 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years. |
| Part 1: INCB099280 Dose 2 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. |
| Part 1: INCB099280 Dose 3 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years. |
| Part 2: INCB099280 Dose selected from Part 1 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB099280Administered as specified in the treatment arm description. | Drug | Part 1: INCB099280 Dose 1, Part 1: INCB099280 Dose 2, Part 1: INCB099280 Dose 3, Part 2: INCB099280 Dose selected from Part 1 |
Primary outcome
Objective response rate (ORR)
Time frame: 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 Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
Number of participants with TEAEs leading to dose modification or discontinuation
Time frame: Up to 2 years
Number of participants with TEAEs leading to dose modification or discontinuation.
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration Of Response (DOR)
Time frame: Up to 2 years
Time to Response (TTR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
INCB099280 pharmacokinetic (PK) 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)
Results and safety
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell CarcinomaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
77 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB099280 in people with Cutaneous Squamous Cell Carcinoma, run by Incyte Corporation at 77 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in France, Spain, Brazil, Romania, South Africa and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.