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Inclusion Criteria:

* Non-small cell lung cancer (NSCLC) Cohort: Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic; No activating EGFR mutations, ALK or ROS1 translocations/rearrangements where testing is standard of care; received at least 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC; No more than 2 prior lines of systemic therapy for locally advanced or metastatic disease (If disease progression occurred during or within 6 months after neoadjuvant/adjuvant chemotherapy or radiotherapy-chemotherapy, the regimen is counted as 1 prior treatment regimen towards the allowed limit of prior treatment regimens); Checkpoint inhibitor naïve.
* Urothelial Cancer (UC) Cohort: Histologically or cytologically confirmed diagnosis of transitional cell carcinoma (TCC) of the urothelium (if mixed, more than 50% TCC component) including bladder, urethra, ureters, or renal pelvis that is locally advanced or metastatic; No prior systemic treatment for locally advanced or metastatic disease; Prior neoadjuvant or adjuvant therapy is permitted if disease progression occurred \>12 months after the completion of therapy; Checkpoint inhibitor naïve; Ineligible for receiving cisplatin-containing front-line chemotherapy based at least one of the following criteria: ECOG performance status (PS) 2; Renal dysfunction (defined as creatinine-clearance \<60 ml/min); Grade 2 peripheral neuropathy; Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies).
* At least 1 measurable lesion by RECIST v1.1 not previously irradiated.
* Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or metastatic specimen or 15 unstained slides (10 minimum). If an archived sample is not available, a fresh tumor biopsy must be performed.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. For UC patients, ECOG performance 2 is permitted (cisplatin ineligibility criterion)

Exclusion Criteria:

* Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-GITR, anti-LAG-3, anti-TIM-3 or anti-CTLA-4 antibody (including ipilimumab).
* Newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.
* Radiologically documented evidence of major blood vessel invasion or encasement by cancer or intratumor cavitation, regardless of tumor histology.
* Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent).
* Current use of immunosuppressive medication (except for those listed in protocol).
* Known prior severe hypersensitivity to the investigational products /monoclonal antibodies.
* Known history of immune-mediated colitis, inflammatory bowel disease, immune-mediated pneumonitis, pulmonary fibrosis.
* NCI CTCAE Grade 3 hemorrhage within 28 days prior to study enrollment.

• Glendale, Arizona, United States
• Goodyear, Arizona, United States
• Phoenix, Arizona, United States
• Phoenix, Arizona, United States
• Tempe, Arizona, United States
• Glendale, California, United States
• Long Beach, California, United States
• Santa Ana, California, United States
• Whittier, California, United States
• Springfield, Missouri, United States
• Omaha, Nebraska, United States
• Omaha, Nebraska, United States
• Greenville, South Carolina, United States
• Greenville, South Carolina, United States
• Kecskemét, Hungary
• Pécs, Hungary
• Törökbálint, Hungary
• Roma, Italy
• Roma, Italy
• Roma, Italy
• Roma, Italy
• Warsaw, Masovian Voivodeship, Poland
• Grudziądz, Poland
• Szczecin, Poland
• Warsaw, Poland
• Pyatigorsk, Stavropol Territory, Russia
• Moscow, Russia
• Moscow, Russia
• Moscow, Russia
• Moscow, Russia
• + 9 more on CT.gov