Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers

Exclusion Criteria

• •Active infection requiring treatment within 3 days of enrollment
• •Other active neoplastic disease (cancer) requiring concurrent anti-neoplastic treatment
• •Known, suspected or documented parenchymal brain metastases unless patient is stable after being treated with surgery and/or radiation
• •Active or previously documented autoimmune or inflammatory disorders such as, but not limited to rheumatoid arthritis, systemic lupus erythematosus, uveitis, ulcerative colitis, Crohn's syndrome, Wegener's syndrome, multiple sclerosis, myasthenia gravis, scleroderma, and sarcoidosis
• •The following are exceptions to this criterion:
• •Vitiligo or psoriasis not requiring systemic treatment (within the last 2 years)
• •Endocrinopathies (e.g., following Hashimoto syndrome) stable on hormone replacement or do not require any therapy
• •* History of primary immunodeficiency
• •* History or prior allogeneic organ transplant 7. The use of immunosuppressive agents within 28 days of enrollment (D-13; obinutuzumab pretreatment) including, but not limited to, cyclosporine, mycophenolate, azathioprine, methotrexate, adalimumab, infliximab, vedolizumab, tofacitinib, dupilumab, rituximab, etc. and including pharmacologic doses of glucocorticoids defined as glucocorticoid equivalents of \>10 mg/day of prednisone (with the exception of systemic steroids given as a premedication before each of the study medications, or used prior to administration of radiographic contrast material in subjects with allergies) are not acceptable within 14 days prior to enrollment. Subjects are permitted to receive topical, intranasal, inhalational, and intra-ocular glucocorticoids
• •* Have received a live attenuated vaccine within 28 days prior to the first dose of Obi
• •* HIV infection that is not considered well-controlled
• •* Pregnant or breastfeeding
• •* Participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of study treatment
• •* Participation in an investigational drug study within the past 4 weeks
• •* Major surgery or trauma within 4 weeks of study entry (D-13; obinutuzumab pre-treatment)
• •* Previous treatment with one of the study drugs (NAP, pembro or Obi)
• •* Certain cardiovascular conditions like current or recent CHF, myocardial infarction, acute coronary syndrome, ongoing angina pectoris, severe peripheral vascular disease, or CVA (stroke). Your doctor will discuss eligibility with you in more detail
• •* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
• •* History of progressive multifocal leukoencephalopathy (PML)