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Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

NCT03775265 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2026-05-04

No results posted yet for this study

Summary

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. 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. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Conditions

  • Bladder Urothelial Carcinoma
  • Muscle Invasive Bladder Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8

Interventions

DRUG

Atezolizumab

Given IV

PROCEDURE

Biopsy of Bladder

Undergo a bladder biopsy

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT or MRI

PROCEDURE

Cystoscopy

Undergo a cystoscopy

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo CT or MRI

DRUG

Mitomycin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo 3DCRT or IMRT

OTHER

Survey Administration

Ancillary studies

PROCEDURE

Transurethral Resection of Bladder Tumor

Undergo a TURBT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Parminder Singh · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2027-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775265 on ClinicalTrials.gov