Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer

Exclusion Criteria

• •Non-muscle invasive, localized bladder cancer (Tis, Ta, T1)
• •Presence of distant metastatic disease or disease not amenable to radiation treatment
• •Prior radiation treatment to the pelvis
• •Prior cystectomy
• •Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks of the first dose of treatment
• •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• •Has a known history of active tuberculosis (TB) (Mycobacterium tuberculosis)
• •Hypersensitivity to pembrolizumab or any of its excipients
• •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
• •Prior systemic chemotherapy for bladder cancer; prior intravesical chemotherapy for the treatment of non-muscle invasive urothelial bladder cancer (UBC) is allowed
• •Upper tract urothelial carcinoma
• •Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
• •* Note: subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
• •* Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• •Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• •Has known distant metastases; clinically involved pelvic nodes (N1-N3) are allowed
• •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with 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; topical and inhaled corticosteroids are allowed
• •Has known history of, or any evidence of active, non-infectious pneumonitis
• •Has an active infection requiring systemic therapy
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
• •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
• •Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
• •Has known active hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
• •* Patients with past hepatitis B virus (HBV) infection or resolved HBV infection, defined as the presence of hepatitis B core antibody (HBc Ab) and absence of hepatitis B surface antigen (HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to day 1 of therapy, but detection of HBV DNA in these patients will not exclude study participation
• •* Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
• •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans)
• •Has a history of (non-infectious) pneumonitis that required steroids, or has current pneumonitis
• •Has received a live vaccine within 30 days of planned start of study therapy
• •* Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed