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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Clinical Observation — OTHER
  Undergo observation
• Computed Tomography — PROCEDURE
  Undergo a CT scan
• CT Urography — PROCEDURE
  Undergo a CT urography
• Cystoscopy — PROCEDURE
  Undergo a cystoscopy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo a MRI
• Pembrolizumab — BIOLOGICAL
  Given IV
• Pharmacological Study — OTHER
  Correlative studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Nov 3, 2017

Status verified

Jun 2026

Primary completion

Aug 8, 2026

Completion

Aug 8, 2026

Study Design

Enrollment

739 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (pembrolizumab)
  Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, CT urography, and/or MRI throughout the trial. Patients may also undergo a cystoscopy and blood sample collection during screening and on study.
• Active Comparator: Arm B (observation)
  Patients undergo observation. Patients undergo a CT scan, CT urography, and/or MRI throughout the trial. Patients may also undergo a cystoscopy and blood sample collection during screening and on study.

Primary Outcome Measure

Overall survival [ Time Frame: From randomization to the date of death from any cause, assessed up to 5 years ]

Locations (914)

Related coverage on Hipa.ai

• Pembrolizumab Phase 3 Trial for Urothelial Cancer Reaches Primary Completion
  Pembrolizumab · Jun 1, 2026 · ClinicalTrials.gov

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