This phase II trial studies how well atezolizumab when given with glycosylated recombinant
human interleukin-7 (CYT107) works in treating patients with urothelial carcinoma that has
spread to nearby tissue or lymph nodes (locally advanced), cannot be removed by surgery
(inoperable), or has spread to other places in the body (metastatic). Immunotherapy with
monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. CYT107 is a
biological product naturally made by the body that may stimulate the immune system to destroy
tumor cells. Giving atezolizumab and CYT107 may work better in treating patients with locally
advanced, inoperable, or metastatic urothelial carcinoma compared to atezolizumab alone.
I. To determine the clinical efficacy of the investigational treatment combination.
I. To determine the clinical activity and toxicity of the investigational treatment
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.
I. To determine the immune correlates of the clinical activity of the investigational
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
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.
Advanced Bladder Urothelial Carcinoma, Advanced Ureter Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Bladder Urothelial Carcinoma, Recurrent Renal Pelvis Urothelial Carcinoma, Recurrent Ureter Urothelial Carcinoma, Recurrent Urethral Urothelial Carcinoma, Stage III Bladder Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8, Stage III Ureter Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Renal Pelvis Cancer AJCC v8, Stage IV Ureter Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Stage IVA Bladder Cancer AJCC v8, Stage IVB Bladder Cancer AJCC v8, Unresectable Bladder Urothelial Carcinoma, Unresectable Renal Pelvis Urothelial Carcinoma, Unresectable Ureter Urothelial Carcinoma
laboratory biomarker analysis,
Glycosylated Recombinant Human Interleukin-7
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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