Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease)
• Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the sub- epithelial connective tissue) disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was performed within 12 months after completion of adequate BCG therapy.
• Adequate BCG is defined as at least 5 treatments with induction BCG followed by at least 2 BCG treatments as reinduction or maintenance
• Ineligible for radical cystectomy or refusal of radical cystectomy
• Adequate organ function Key

Exclusion Criteria

• Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior organ transplant
• Prior treatment with adenovirus-based cancer therapy
• Prior therapy with or intolerant to prior checkpoint inhibitor therapy
• Clinically significant or active cardiac disease
• Active autoimmune disease