Cutaneous Squamous Cell Carcinoma
Conditions
Keywords
Cutaneous Squamous Cell Carcinoma, Anti-PD-L1 antibody, Metastatic cutaneous squamous cell carcinoma, Locally advanced cutaneous squamous cell carcinoma
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.
Interventions
DRUGINCB099280
Administered as specified in the treatment arm description.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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) | 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 | Up to 2 years | Number of participants with TEAEs leading to dose modification or discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 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. |
| Progression-free survival (PFS) | 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. |
| Time to Response (TTR) | 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. |
| Duration Of Response (DOR) | 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. |
| Overall Survival (OS) | Up to 2 years | Defined as the time from the date of first dose to death due to any cause. |
| INCB099280 pharmacokinetic (PK) in Plasma | 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 |
Countries
Australia, Brazil, Canada, Chile, Croatia, France, Hungary, Montenegro, New Zealand, North Macedonia, Romania, South Africa, South Korea, Spain, Turkey (Türkiye)
Contacts
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed