Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

Exclusion Criteria

• •Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monocolonal antibodies.
• •Known history of: immune-mediated colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.
• •Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
• •Prior organ transplantation including allogenic stem cell transplantation.
• •Vaccination within 4 weeks prior to C1D1 and while on trial is prohibited except for administration of inactivated vaccines.
• •Known symptomatic brain lesions requiring steroids.
• •Known history of testing positive for human immunodeficiency virus (HIV or known acquired immunodeficiency syndrome (AIDS).
• •Positive HBV surface antigen or HCV test indicating acute or chronic infection..
• •Active infection requiring systemic therapy
• •Clinically significant (i.e., active) cardiovascular disease including the following: documented left ventricular ejection fraction (LVEF) \<50% by ECHO/MUGA; cerebral vascular accident/stroke or transient ischemic attack; myocardial infarction; unstable angina; congestive heart failure or serious cardiac arrhythmia (uncontrolled, clinically significant) requiring medication.
• •Diagnosis of any other malignancy within 2 years prior to C1D1, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix and for Combination A only, low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration) or adequately treated prostate cancer.
• •Current use of immunosuppressive medication at the time of study enrollment.
• •Major surgery within 4 weeks prior to study enrollment.
• •Conditions that may impair intake or absorption such as inability to swallow capsules or tablets; known malabsorption syndrome; or baseline diarrhea ≤ Grade 1.
• •Participation in other studies involving investigational drug(s) within 2 weeks prior to C1D1.