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

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.

Conditions

• Bladder Adenocarcinoma
• Bladder Mixed Adenocarcinoma
• Bladder Squamous Cell Carcinoma
• Bladder Urothelial Carcinoma
• Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
• Infiltrating Bladder Urothelial Carcinoma With Giant Cells
• Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation
• Infiltrating Bladder Urothelial Carcinoma With Trophoblastic Differentiation
• Infiltrating Bladder Urothelial Carcinoma, Clear Cell Variant
• Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
• Infiltrating Bladder Urothelial Carcinoma, Nested Variant
• Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Cystectomy

Undergo cystectomy

DRUG

Doxorubicin

Given IV

BIOLOGICAL

Durvalumab

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Methotrexate

Given IV

DRUG

Vinblastine

Given IV

Sponsors & Collaborators

• AstraZeneca

  collaborator INDUSTRY

• Stanford University

  lead OTHER

Principal Investigators

• Sandy Srinivas · Stanford Cancer Institute Palo Alto

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-10

Primary Completion

2022-08-11

Completion

2022-08-11

FDA Drug

Yes

Countries

• United States

Study Locations