Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer

Inclusion Criteria

• Patients must have a histologically documented recurrence of non-muscle-invasive bladder carcinoma (T1HG, T1HG after repeat transurethral resection [reTUR]) or BCG refractory; if patient has received BCG they can be Ta, Tis, or T1)
• Patients must have persistent high grade disease OR be BCG refractory, defined as either:
• Recurrence within 6 months of receiving at least 2 courses of intravesical BCG (at least 5 or 6 inductions and at least 2 or 3 maintenance doses) or
• T1 high grade disease at the first evaluation following induction BCG alone (at least 5 of 6 induction doses)
• Patients must agree to provide tissue from archival biopsy samples or newly obtained excisional biopsy of a tumor lesion
• NOTE: Patients who do not have available specimens from previous biopsy or do not agree to provide this tissue are not eligible; cytological specimens will not be acceptable; availability of tissue must be confirmed at the time of registration, but the actual sample does not have to be received in order to complete registration
• Patients must have received one course of induction treatment with BCG (4-6 weekly doses), irrespective of the interval since last treatment; patients are allowed to have received any number of prior chemotherapy instillations
• NOTE: Patients may have received prior intravesical interferon
• All patients must have imaging (computed tomography [CT] scan or magnetic resonance imaging [MRI]) documenting normal upper urinary tracts and absence of locally advanced bladder cancer within 60 days prior to study registration
• Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Absolute neutrophil count (ANC) >= 1, 500 /mcL within 14 days prior to registration
• Platelets >= 100, 000 / mcL within 14 days prior to registration
• Hemoglobin >= 9 g/dL or >= 5.6 mmol/L within 14 days prior to registration
• Serum creatinine = = 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN within 14 days prior to registration
• Serum total bilirubin = 1.5 ULN within 14 days prior to registration
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = 12 months)
• FOCBP must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria

• Patients who have had chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day -14 or who have not recovered (to =< grade 1 or baseline) from adverse events due to a previously administered agent are not eligible
• Note: subjects with =< grade 2 neuropathy are an exception to this criterion and do qualify for the study
• Note: if subject received major surgery within 4 weeks prior to day -14, they must have recovered adequately from the toxicity and/or complications per PI discretion
• Patients may not be receiving any other investigational agents within 4 weeks of the first dose of treatment
• Patients who have received a prior monoclonal antibody within 4 weeks prior to study day -14 or who have not recovered (to =< grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier are not eligible
• Patients who have a diagnosis of immunodeficiency (per PI discretion) or who have received treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to study registration are not eligible
• NOTE: patients who have received acute, low-dose, systemic immunosuppressant medications