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NCT Number: NCT05888844

A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Border Medical Oncology Research Unit, Albury, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INCB099280

Drug

Administered as specified in the treatment arm description.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: Up to 2 years

    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.

  2. Duration Of Response (DOR)

    Time frame: Up to 2 years

    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.

  3. Time to Response (TTR)

    Time frame: Up to 2 years

    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.

  4. Progression-free survival (PFS)

    Time frame: Up to 2 years

    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.

  5. Overall Survival (OS)

    Time frame: Up to 2 years

    Defined as the time from the date of first dose to death due to any cause.

  6. 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)

    INCB099280 concentration in plasma

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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