drugset
drugset / Trial / NCT03912818

Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer

NCT03912818 ↗

Phase 2 Terminated 7 enrolled Stanford University AstraZeneca · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects of durvalumab and chemotherapy before surgery in treating patients with variant histology bladder cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, cisplatin, gemcitabine, and carboplatin, 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 durvalumab in addition to standard chemotherapy may lead to better outcomes in patients with variant histology bladder cancer.

Timeline

Start
2019-04-10
Primary completion
2022-08-11
Completion
2022-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 30 mg/m2 Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Methotrexate Small molecule 30 mg/m2 Intravenous
Subject Vinblastine Small molecule 3 mg/m2 Intravenous

Indications

bladder mixed adenocarcinoma bladder squamous cell carcinoma infiltrating bladder urothelial carcinoma sarcomatoid variant infiltrating bladder urothelial carcinoma, clear cell variant micropapillary variant infiltrating bladder urothelial carcinoma nested variant infiltrating bladder urothelial carcinoma plasmacytoid variant infiltrating bladder urothelial carcinoma