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

Summary

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.

Conditions

• 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

Interventions

DRUG

Atezolizumab

Given IV

PROCEDURE

Biopsy

Undergo biopsy of tumor

PROCEDURE

Biospecimen Collection

Undergo collection of blood and stool samples

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Glycosylated Recombinant Human Interleukin-7

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography and Computed Tomography Scan

Undergo PET/CT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Evan Y Yu · Cancer Immunotherapy Trials Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-05

Primary Completion

2023-09-30

Completion

2024-04-01

FDA Drug

Yes

Countries

• United States

Study Locations