Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

Exclusion Criteria

• •Prior treatment with immune checkpoint blockade therapy
• •Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy, within 2-4 weeks prior first study treatment
• •Corrected QT interval (QTc) ≥480 msec using Fredericia's QT correction formula (based on an average of triplicate recordings)
• •Prior allogeneic stem cell or solid organ transplantation
• •Prior treatment with drugs that stimulate the immune system within 4 weeks prior to first study treatment
• •Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
• •Received a live, attenuated vaccine within 4 weeks prior to first study treatment, or may need to receive a vaccine during study treatment
• •Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
• •Prior pulmonary fibrosis, pneumonia, or pneumonitis
• •Cancer other than prostate within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin
• •Prior treatment with an agent targeting the adenosine pathway
• •No oral or IV antibiotics within 2 weeks prior to first study treatment
• •No severe infection within 4 weeks prior to first study treatment
• •No clinically significant cardiac disease
• •Inability to swallow medications
• •Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy (prior docetaxel \[up to 6 cycles\] for hormone-sensitive prostate cancer is allowed if the last dose was at least 6 months prior to study treatment initiation)
• •Prior treatment with enzalutamide or similar therapy other than abiraterone
• •Active or history of autoimmune disease or immune deficiency
• •History of severe allergic reactions to antibody therapy
• •Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
• •Prior treatment with docetaxel, cabazitaxel, or other taxane chemotherapy
• •Active or history of autoimmune disease or immune deficiency
• •History of severe allergic reactions to antibody therapy
• •Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment
• •Prior treatment with docetaxel, cabazitaxel, topoisomerase 1 inhibitors, or other taxane chemotherapy
• •Active or history of autoimmune disease or immune deficiency
• •History of severe allergic reactions to antibody therapy
• •Concomitant use of a medication prohibited by the protocol (including certain transporter substrates as well as known strong CYP3A4 inducers and CYP3A4 inhibitors) within 4 weeks prior to and throughout study treatment