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Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer

NCT04383743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-09-18

Study results available
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Summary

This pilot study is evaluating how well pembrolizumab and combination chemotherapy before surgery work for the treatment of specific types of muscle-invasive bladder cancer that have unusual appearance (variants). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, adriamycin, and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and combination chemotherapy before surgery may work better in treating patients with these muscle invasive bladder cancer variants compared to chemotherapy alone.

Conditions

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

Interventions

DRUG

Cisplatin

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Methotrexate

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Radical Cystectomy

Undergo standard of care radical cystectomy

DRUG

Vinblastine Sulfate

Given IV

Sponsors & Collaborators

Principal Investigators

  • Petros Grivas · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2024-06-17
Completion
2025-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04383743 on ClinicalTrials.gov