Figure 4.

Subject exclusion criteria for phase I study of pembrolizumab in combination with Bacillus Calmette-Guérin for patients with high risk non-muscle invasive bladder cancer. ^*Chest X-ray, CT urogram or MRI and urogram are allowed to ascertain the superficial nature of the disease when indicated, but not required. If urogram protocol is not available or contrast allergy/poor renal function precludes such imaging, then non-contrast CT or MRI of the abdomen/pelvis within 90 days of study entry will suffice. ^†Exceptions include upper urinary tract transitional cell cracinoma (TCC), basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy. ^‡Use of disease-modifying agents, corticosteroids or immunosuppressive drugs. Replacement therapy (eg, thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment. PD, programmed death.