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New drug shows promise for advanced skin cancer in early trial

NCT ID NCT05888844

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests a new drug called INCB099280 in 63 adults with advanced squamous cell skin cancer that cannot be removed by surgery or radiation. The main goals are to see if the drug shrinks tumors and to check its safety. Participants take the drug and are monitored for side effects and cancer response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous squamous cell carcinoma

Contacts and locations

Locations

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900, Brazil

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Avicenne Hospital

    Bobigny, 93000, France

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux, 33075, France

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 02640, Australia

  • Box Hill Hospital

    Box Hill, Victoria, 03128, Australia

  • Cdiem - Centro de Investigacion Y Especialidades Medicas

    Santiago, 00000, Chile

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093, France

  • Centre Hospitalier de Pau - Hôpital François Mitterrand

    Pau, 64046, France

  • Centrul de Oncologie Sf. Nectarie Craiova

    Craiova, 200347, Romania

  • Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina

    Florianópolis, 88034-000, Brazil

  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo André, 09060-650, Brazil

  • Cha Bundang Medical Center

    Seongnam-si, 13496, South Korea

  • Chris Hani Baragwanath Hospital

    Johannesburg, 01864, South Africa

  • Chru de Lille Hopital Claude Huriez

    Lille, 59037, France

  • Chu Dijon - Hôpital François Mitterrand

    Dijon, 21079, France

  • Chu Hopital de La Timone

    Marseille, 13385, France

  • Chu de Clermont - Ferrand- Hospital Estaing

    Clermont-Ferrand, 63003, France

  • Chu de Nice - Hospital L Archet

    Nice, 06200, France

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008, Spain

  • Clinical Center of Montenegro

    Podgorica, 81000, Montenegro

  • Clinical Research Chile Spa.

    Valdivia, 5090000, Chile

  • Clinical Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210-120, Brazil

  • Fundacao Pio Xii Hospital de Cancer de Barretos

    Barretos, 14784-400, Brazil

  • Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hgb - Hospital Giovanni Battista - Mae de Deus Center

    Porto Alegre, 90110-270, Brazil

  • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

    Rouen, 76031, France

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hospital Ambroise Pare

    Boulogne-Billancourt, 92100, France

  • Hospital Clinic Barcelona Main

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Saint Louis

    Paris, 75010, France

  • Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-080, Brazil

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Ico Institut Catala D Oncologia

    L'Hospitalet de Llobregat, 08906, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto de Oncologia Saint Gallen

    Santa Cruz do Sul, 96810-110, Brazil

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015, Romania

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • James Lind Centro de Investigacion Del Cancer

    Temuco, 4800827, Chile

  • Johese Clinical Research: Midstream

    Centurion, 01692, South Africa

  • McGill University Jewish General Hospital

    Montreal, Quebec, H4A 3J1, Canada

  • Medical Park Seyhan Hospital

    Adana, 01140, Turkey (Türkiye)

  • Medisprof

    Cluj-Napoca, 400641, Romania

  • Monash Medical Centre Clayton

    Clayton, Victoria, 03168, Australia

  • Oncomed Srl

    Timișoara, 300239, Romania

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    Ijuí, 98700-000, Brazil

  • Pecsi Tudomanyegyetem

    Pécs, 07632, Hungary

  • Phoenix Pharma (Pty) Ltd

    Port Elizabeth, 06001, South Africa

  • Princess Alexandra Hospital Australia

    Woolloongabba, Queensland, 04102, Australia

  • Q.E. Ii Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • S.C Policlinica Ccbr S.R.L

    Bucharest, 30463, Romania

  • S.C. Sigmedical Services Srl

    Suceava, 720284, Romania

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Semmelweis Egyetem

    Budapest, 01085, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Specialty Hospital Medico

    Rijeka, 51000, Croatia

  • The Medical Oncology Centre of Rosebank

    Johannesburg, 02196, South Africa

  • Townsville Cancer Centre

    Townsville, Queensland, 04814, Australia

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • University Clinic For Radiotherapy and Oncology

    Skopje, 01000, North Macedonia

  • University Hospital Centre Sestre Milosrdnice

    Zagreb, 10000, Croatia

  • University Hospital of Saint Etienne

    Saint-Etienne, 42055, France

  • University of Pretoria Oncology Department

    Pretoria, 00084, South Africa

  • Waikato Hospital

    Hamilton, 03200, New Zealand

  • Wits Clinical Research

    Johannesburg, 02193, South Africa

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Other studies related to the condition(s) this trial covers.