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 11 Locations for this study

See Locations Near You

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
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
Johese Clinical Research: Midstream
Centurion , 01692, South Africa
Mary Potter Oncology Centre
Pretoria , 00181, South Africa

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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