Melanoma Clinical Trial

Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Summary

The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Prior systemic therapy, diagnoses and disease setting as follows:

For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following,

Unresectable or metastatic cutaneous melanoma, or
Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or
Intermediate or poor-risk advanced clear cell RCC, or
MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.

For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following,

Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or
Intermediate - or poor-risk advanced clear cell RCC.
ECOG performance score of 0 or 1.
Life expectancy > 3 months, in the opinion of the investigator.

Histologically confirmed solid tumors with measurable disease per RECIST v1.1.

Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria.
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.
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 of clinically significant cardiac disease.
History of evidence of interstitial lung disease including non-infections pneumonitis.
Presence of gastrointestinal condition that may affect drug absorption
Any autoimmune disease requiring systemic treatment in the past 5 years.
Diagnosis of 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 system antibiotics within 28 days of first dose of study treatment.
Probiotic usage is prohibited during the screening and throughout the study treatment period.
Received a live vaccine within 28 days of planned start of study drug.
Laboratory values outside the Protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05909995

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 31 Locations for this study

See Locations Near You

Hgb - Hospital Giovanni Battista - Mae de Deus Center
Fullerton California, 92835, United States
Valkyrie Clinical Trials
Los Angeles California, 90067, United States
UC Irvine Medical Center
Orange California, 92868, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
University of North Carolina At Chapel Hill
Chapel Hill North Carolina, 27514, United States
Alliance For Multispecialty Research Llc
Knoxville Tennessee, 37920, United States
Cancer Research Sa
Adelaide South Australia, 05000, Australia
Box Hill Hospital
Box Hill Victoria, 03128, Australia
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
Curitiba , 81520, Brazil
Centro Regional Integrado de Oncologia
Fortaleza , 60336, Brazil
Fundacao Doutor Amaral Carvalho
JAÚ , 17210, Brazil
Hospital de Cancer de Londrina
Londrina , 86015, Brazil
Oncocentro - Belo Horizonte
Nova Lima , 34006, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo , 99010, Brazil
Clinica Lacks - Unidade de Pesquisas Clinicas Em Oncologia (Upco)
Pelotas , 96020, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90020, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
Hospital Nossa Senhora Da Conceicao
Porto Alegre , 91350, Brazil
Hospital Das Clínicas Fmrp-Usp
Ribeirão Preto , 14048, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz Do Sul , 96810, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto , 15090, Brazil
A. C. Camargo Cancer Center
São Paulo , 01509, Brazil
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
McGill University Health Centre/Glen Site/Cedars Cancer Centre
Montreal Quebec, H4A3J, Canada
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara , 44280, Mexico
Vestre Viken Hf Drammen Sykehus
Drammen , 03004, Norway
Akershus University Hospital
Lorenskog , 01478, Norway
Narodny Onkologicky Ustav
Bratislava , 83310, Slovakia
Skaenes Universitetssjukhus Lund
Lund , 22185, Sweden
Karolinska Institute Universitetssjukhuset Solna
Stockholm , 17176, Sweden

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05909995

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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