Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

Summary

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine 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. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Conditions

• Renal Pelvis and Ureter Urothelial Carcinoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Doxorubicin Hydrochloride

Given Iv

BIOLOGICAL

Durvalumab

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Methotrexate

Given IV

BIOLOGICAL

Pegfilgrastim

Given via injection

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

DRUG

Vinblastine Sulfate

Given Iv

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jean H Hoffman-Censits · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-12

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States

Study Locations