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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Metastatic Non-small Cell Lung Cancer
• Locally Advanced Urothelial Cancer
• Metastatic Urothelial Cancer
• Unresectable Melanoma
• Metastatic Melanoma
• Locally Advanced Renal Cell Carcinoma
• Metastatic Clear-Cell Renal Cell Carcinoma

ELIGIBILITY

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.

- * 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Mark Cornfeld, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION