Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy

Sponsor
Hellenic GenitoUrinary Cancer Group
Study ID
NCT03993249
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    standard of care chemoradiotherapy + Nivolumab
  • chemoradiotherapy — OTHER
    standard of care chemoradiotherapy

Study Details

The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy

Key Dates

Start date
May 28, 2019
Status verified
Mar 2022
Primary completion
Aug 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Chemoradiotherapy
    standard of care chemo-radiotherapy
  • Experimental: Combination
    standard of care chemo-radiotherapy + Nivolumab

Primary Outcome Measure

Locoregional control rate [ Time Frame: 2 years ]

Central Contacts

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