This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Administered as specified in the treatment arm description.
Objective response rate (ORR)
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.
Time frame: Up to 2 years
Number of participants with Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: Up to 2 years 3 months
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Time frame: Up to 2 years
Disease Control Rate (DCR)
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.
Time frame: Up to 2 years
Duration Of Response (DOR)
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.
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Townsville Cancer Centre
Townsville, Queensland, Australia
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre Clayton
Clayton, Victoria, Australia
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, Brazil
Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina
Florianópolis, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Brazil
...and 67 more locations
Time to Response (TTR)
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.
Time frame: Up to 2 years
Progression-free survival (PFS)
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 frame: Up to 2 years
Overall Survival (OS)
Defined as the time from the date of first dose to death due to any cause.
Time frame: Up to 2 years
INCB099280 pharmacokinetic (PK) in Plasma
INCB099280 concentration 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)