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

Sponsor
Technical University of Munich
Study ID
NCT03529890
Phase
PHASE2
Status
Unknown

Conditions

  • Urinary Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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 therapy of the pelvis — RADIATION
    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)
  • Radical cystectomy with standardized pelvic lymphadenectomy — PROCEDURE
    Radical cystectomy with standardized bilateral pelvic lymphadenectomy: performed between week 11 - 15 (Aim: week 13)

Study Details

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

Key Dates

Start date
Feb 4, 2019
Status verified
Dec 2021
Primary completion
Apr 14, 2022
Completion
Aug 31, 2023

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radio-Immunotherapy before cystectomy
    Single arm treatment with Nivolumab during a neoadjuvant radiation therapy of the pelvis before radical cystectomy with standardized pelvic lymphadenectomy

Primary Outcome Measure

Rate of patients with completed Treatment [ Time Frame: end of week 15 ]

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