A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document;
2. Any prior therapy is permitted except prior therapy with PD1/PDL1 inhibitor.
3. Histologic diagnosis of metastatic renal cell carcinoma or urothelial cancer;
4. Patients must have at least 2 distinct measurable metastatic sites at least 1 cm orlarger in their largest diameter per RECIST 1.1
5. Patients must have adequate organ and marrow function as defined by initial laboratorytests.
6. At least 2 weeks since last chemotherapy and 4 weeks since last immunotherapytreatment.
7. Performance status Eastern cooperative oncology group (ECOG) 0-1
8. Men and women, ages > 18 years of age.
9. Life expectancy > 3 months
10. Stable brain metastases for at least 4 weeks and not steroid dependent
11. Women of childbearing potential (WOCBP) must be using an adequate method ofcontraception to avoid pregnancy throughout the study and for up to 8 weeks after thestudy in such a manner that the risk of pregnancy is minimized. Should a woman becomepregnant or suspect she is pregnant while she is enrolled in this study, she shouldinform her treating physician immediately.

Exclusion Criteria:

1. Patients having no lesions outside the field of radiation thus nullifying the abilityto measure an abscopal effect;
2. Any other malignancy from which the patient has been disease-free for less than 5years, with the exception of adequately treated and cured basal or squamous cell skincancer, superficial bladder cancer or carcinoma in situ of the cervix;
3. Autoimmune/auto inflammatory disease: Patients with a history of inflammatory boweldisease are excluded from this study as are patients with a history of symptomaticdisease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma],Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis];
4. Any underlying medical or psychiatric condition, which in the opinion of theInvestigator, will make the administration of study drug hazardous or obscure theinterpretation of adverse events (AEs), such as a condition associated with frequentdiarrhea;
5. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up toone month prior to or after any dose of PD-1/PDL-1 blocking antibody).
6. A history of prior treatment with PD-1/PDL-1blocking antibody;
7. Patients who have had immunotherapy within 4 weeks prior to entering the study.
8. Concomitant therapy with any of the following: interleukin -2 (IL-2), interferon orother non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressiveagents; other investigation therapies; or chronic use of systemic corticosteroids;
9. Patients undergoing therapy with other investigational agents or other chemotherapyagents;
10. Women who:
11. are unwilling or unable to use an acceptable method to avoid pregnancy for theentire study period and for at least 8 weeks after cessation of study drug, or
12. have a positive pregnancy test at baseline, or
13. are pregnant or breastfeeding
14. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) fortreatment of either a psychiatric or physical (e.g., infectious) illness