CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Cisplatin +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04383743
NCT04383743Phase 2Completed

Pembrolizumab and aMVAC Chemotherapy as Neoadjuvant Therapy in Non-Urothelial Histology Muscle-Invasive Bladder Cancer: A Pilot Trial

University of Washington·interventional·Posted May 12, 2020·Updated Sep 18, 2025

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Doxorubicin, and 5 other interventions for Stage II Bladder Cancer AJCC v8 and 2 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 12, 2020
Enrollment StartNov 24, 2020
Primary CompletionJun 17, 2024
Study CompletionMar 4, 2025
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.1 years ago

Interventions

Cisplatindrug

Given IV

Doxorubicindrug

Given IV

Methotrexatedrug

Given IV

Pegfilgrastimbiological

Given SC

Pembrolizumabbiological

Given IV

Radical Cystectomyprocedure

Undergo standard of care radical cystectomy

Vinblastine Sulfatedrug

Given IV