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Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer

NCT03244384 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.

Conditions

  • Localized Renal Pelvis and Ureter Urothelial Carcinoma
  • Locally Advanced Bladder Urothelial Carcinoma
  • Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma
  • Locally Advanced Ureter Urothelial Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
  • Stage II Renal Pelvis and Ureter Cancer AJCC v7
  • Stage II Ureter Cancer AJCC v7
  • Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
  • Stage III Renal Pelvis and Ureter Cancer AJCC v7
  • Stage III Ureter Cancer AJCC v7

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Clinical Observation

Undergo observation

PROCEDURE

Computed Tomography

Undergo a CT scan

PROCEDURE

CT Urography

Undergo a CT urography

PROCEDURE

Cystoscopy

Undergo a cystoscopy

PROCEDURE

Magnetic Resonance Imaging

Undergo a MRI

BIOLOGICAL

Pembrolizumab

Given IV

OTHER

Pharmacological Study

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Andrea B Apolo · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2026-06-01
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States
  • Guam

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 NCT03244384 on ClinicalTrials.gov