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

Exclusion Criteria

• •* 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,
• •* 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.
• •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.