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RecruitingLast updated: 15 May 2024

This study is evaluating how safe, tolerable and effective a new type of immunotherapy is in people with advanced cutaneous squamous cell carcinomaA Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma

Clinical summary


This study consists of two parts. In Part 1, participants with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC will be randomly allocated into one of three cohorts. Each cohort will receive a different dose level of immunotherapy (INCB099280). In Part 2, the dose level identified as being the safest and most effective in Part 1 will be expanded to enrol additional participants with metastatic cSCC and locally advanced cSCC.


This trial is treating patients with previously untreated metastatic, recurrent or locally advanced cutaneous squamous cell carcinoma


Skin Cancers Skin





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Trial Identifiers

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Trial sponsor

Incyte Corporation

Scientific Title

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



  • 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.


  • 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.


  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You are able to swallow medication by mouth.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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