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

Part of paid clinical trials in Riverside, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03513952
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Biopsy — PROCEDURE
    Undergo biopsy of tumor
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and stool samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Glycosylated Recombinant Human Interleukin-7 — BIOLOGICAL
    Given IM
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography and Computed Tomography Scan — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Jun 5, 2019
Status verified
May 2024
Primary completion
Sep 30, 2023
Completion
Apr 1, 2024

Study Design

Enrollment
47 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (CYT107, atezolizumab)
    Patients receive CYT107 IM on days 1, 8, 15, and 22, and atezolizumab 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. Patients also undergo CT and/or MRI scans, and collection of blood and stool samples on study. Patients may also undergo tumor biopsy at screening and on study.
  • Active Comparator: Group 2 (atezolizumab)
    Patients receive atezolizumab IV over 60 minutes on cycle 1. Following cycle 1, 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. Patients also undergo CT and/or MRI scans, and collection of blood and stool samples on study. Patients may also undergo tumor biopsy at screening and on study.
  • Experimental: Safety run in phase
    Patients assigned to the experimental arm (atezolizumab + CYT107). If the treatment combination of the experimental arm demonstrates an acceptable safety profile in the Safety Run-In (one or fewer patient experiences a protocol-defined Dose Limiting-Toxicity), randomized enrollment into the trial will begin. The Run-in phase patients will be analyzed and reported separately both for safety and for efficacy.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Kaiser Permanente-RiversideRiversideCalifornia92505-
Moffitt Cancer CenterTampaFlorida33612-
Straub Clinic and HospitalHonoluluHawaii96813-
University of Hawaii Cancer CenterHonoluluHawaii96813-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
East Jefferson General HospitalMetairieLouisiana70006-
Washington University School of MedicineSt LouisMissouri63110-
Roswell Park Cancer InstituteBuffaloNew York14263-
FHCC South Lake UnionSeattleWashington98109-

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By research site
Kaiser Permanente-Riverside· Riverside, CAMoffitt Cancer Center· Tampa, FLStraub Clinic and Hospital· Honolulu, HIUniversity of Hawaii Cancer Center· Honolulu, HIUniversity of Chicago Comprehensive Cancer Center· Chicago, ILEast Jefferson General Hospital· Metairie, LA

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