Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy
NCT ID: NCT03993249
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
78 participants
INTERVENTIONAL
2019-05-28
2023-12-31
Brief Summary
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Detailed Description
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There is a 24 month accrual period during which 78 patients will be randomized in a control group (standard chemo-radiotherapy) and the treatment group (chemo-radiotherapy + Nivolumab)
The primary objective would be to compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy.
The secondary objectives are
1. To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC
2. To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective)
3. To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
4. Assess the effect of combined treatment on the quality of life
Correlative studies of outcomes with PD-L1expression and with lymphocytic populations in the environment of the tumor
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoradiotherapy
standard of care chemo-radiotherapy
chemoradiotherapy
standard of care chemoradiotherapy
Combination
standard of care chemo-radiotherapy + Nivolumab
Nivolumab
standard of care chemoradiotherapy + Nivolumab
chemoradiotherapy
standard of care chemoradiotherapy
Interventions
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Nivolumab
standard of care chemoradiotherapy + Nivolumab
chemoradiotherapy
standard of care chemoradiotherapy
Eligibility Criteria
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Inclusion Criteria
* Urothelial, squamous or glandular histology according to WHO 2016 classification (Fig 1)
* Undergone a vigorous TURB
* Not candidates for radical cystectomy.
* PS:0-1
* age \>18 years old
* Adequate bone marrow function
* Adequate renal function
Exclusion Criteria
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer cervix or breast.
* Previous systemic chemotherapy or prior biologic agents within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment.
* Prior treatment with any PD-1 or PDL-1 inhibitor or anti CTLA4 agent
* Previous pelvic radiation therapy.
* Patients with inherited syndromes associated with hypersensitivity to ionizing radiation
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation
* Any history of inflammatory bowel disease and or history of abdominal fistula
* Previous allergy to any of the study drugs
18 Years
ALL
No
Sponsors
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Hellenic GenitoUrinary Cancer Group
OTHER
Responsible Party
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Locations
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Hellenic GenitoUrinary Cancer Group
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REQ-0000020479
Identifier Type: -
Identifier Source: org_study_id
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