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Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder

NCT03529890 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-10-20

No results posted yet for this study

Summary

A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder

Conditions

  • Urinary Bladder Cancer

Interventions

DRUG

Nivolumab

Experimental intervention: Immunotherapy with 4 cycles of Nivolumab: 240 mg intravenously every 2 weeks, starting one week before radiotherapy (week1, d1), last infusion on week 7, d1

RADIATION

Radiation therapy of the pelvis

Neoadjuvant radiation therapy of pelvis with 45+5,4 Gy for 6 weeks: 28 x 1.8 Gy including a boost of bladder with 5.4 Gy, starting with week 2 (d1)

PROCEDURE

Radical cystectomy with standardized pelvic lymphadenectomy

Radical cystectomy with standardized bilateral pelvic lymphadenectomy: performed between week 11 - 15 (Aim: week 13)

Sponsors & Collaborators

Principal Investigators

  • Sebastian C Schmid, PD Dr. med · Department of Urology, Klinikum rechts der Isar der Technischen Universität München

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2022-04-14
Completion
2023-08-31

Countries

  • Germany

Study Locations

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Drugs
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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 NCT03529890 on ClinicalTrials.gov