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Trial record 1 of 1 for:    INCB 99280-212
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A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT05888844
Recruitment Status : Recruiting
First Posted : June 5, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Drug: INCB099280 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
Actual Study Start Date : October 9, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: INCB099280 Dose 1
Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
 Drug: INCB099280
Administered as specified in the treatment arm description.
Experimental: Part 1: INCB099280 Dose 2
Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
 Drug: INCB099280
Administered as specified in the treatment arm description.
Experimental: Part 1: INCB099280 Dose 3
Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
 Drug: INCB099280
Administered as specified in the treatment arm description.
Experimental: Part 2: INCB099280 Dose selected from Part 1
Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
 Drug: INCB099280
Administered as specified in the treatment arm description.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05888844


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Incyte Medical Monitor Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05888844    
Other Study ID Numbers: INCB 99280-212
2022-502476-23-00 ( Registry Identifier: EU CT Number )
First Posted: June 5, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Cutaneous Squamous Cell Carcinoma
Anti-PD-L1 antibody
Metastatic cutaneous squamous cell carcinoma
Locally advanced cutaneous squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell