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

Inclusion Criteria:

- Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell
lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal
growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic
tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants
who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a
combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or
metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid
features) and having received no prior systemic therapy.

- Measurable disease per RECIST v1.1.

- Eastern Cooperative Oncology Group performance status 0 to 1.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- 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.

- Active malignancy requiring treatment of a type not included in the study population.

- 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 highly active 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.