A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

Exclusion Criteria

• •Measurable disease per RECIST v1.1.
• •Eastern Cooperative Oncology Group performance status 0 to 1.
• •Willingness to avoid pregnancy or fathering children.
• •Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
• •Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
• •Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is \> 30 Gy.
• •Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
• •Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
• •Laboratory values outside the protocol-defined range at screening.
• •Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry.
• •Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent).
• •Evidence of interstitial lung disease or active noninfectious pneumonitis.
• •Known active central nervous system metastases and/or carcinomatous meningitis.
• •Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
• •Active infections requiring systemic therapy.
• •Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy.
• •Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
• •Impaired cardiac function or clinically significant cardiac disease.
• •Is pregnant or breastfeeding.
• •Has received a live vaccine within 28 days of the planned start of study drug.