Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To determine the clinical efficacy of the investigational treatment combination. SECONDARY OBJECTIVES: I. To determine the clinical activity and toxicity of the investigational treatment combination. II. The clinical benefit rate (CBR), progression-free survival (PFS), duration...

PRIMARY OBJECTIVE: I. To determine the clinical efficacy of the investigational treatment combination. SECONDARY OBJECTIVES: I. To determine the clinical activity and toxicity of the investigational treatment combination. II. The clinical benefit rate (CBR), progression-free survival (PFS), duration of response (DOR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related (ir) RECIST, and overall survival (OS). III. The CBR, PFS, DOR, and OS in all patients and patients stratified by PD-L1 expression levels in the tumor microenvironment. IV. The safety and toxicity of addition of CYT107 to atezolizumab. EXPLORATORY OBJECTIVES: I. To determine the immune correlates of the clinical activity of the investigational treatment combination. II. Explore the effect of the investigational treatment combination on the number and phenotype of tumor-specific T cells in the peripheral blood. III. Investigate for evidence that the investigational treatment combination increases the exposure of bladder cancer-specific antigens (e.g., cancer/testis antigens or neoantigens). IV. Investigate changes in tumor microenvironment that correlate with response or provide information on potential actionable causes for lack of clinical benefit. V. Investigate the potential that administration of atezolizumab with CYT107 may perturb the pharmacokinetics and immunogenicity of CYT107. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP 1: Patients receive CYT107 intramuscularly (IM) on days 1, 8, 15, and 22, and atezolizumab intravenously (IV) over 60 minutes on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. GROUP 2: Patients receive atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 2 years.

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