Table 2. Key exclusion criteria.

Exclusion criteria

(I) Active autoimmune disease that has required systemic treatment using corticosteroids or other immunosuppressive medication

(II) History of serious immune-related adverse events caused by anti-PD-1/anti-PD-L1 antibodies

(III) Patients receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs exceeding 10 mg/day of prednisolone equivalent

(IV) Multiple cancers

(V) Central nervous system metastases (symptomatic or requiring treatment)

(VI) Carcinomatous meningitis

(VII) Evidence of interstitial pneumonia

(VIII) Uncontrollable pleural effusion, ascites, or pericardial fluid

(IX) Underwent radiotherapy within 2 weeks before the first nivolumab and TM5614

(X) Evidence of severe or uncontrolled systemic disease

PD-1, programmed death-1; PD-L1, programmed death ligand 1.