Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy
1 other identifier
interventional
78
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2019
CompletedFirst Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 23, 2022
March 1, 2022
3.2 years
June 4, 2019
March 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Locoregional control rate
To compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
2 years
Secondary Outcomes (4)
Incidence Rate of treatment-related adverse event (safety and tolerability)
2 years
Bladder cancer failure-free (BCFF) rates
2 years
Median overall survival (OS)
2 years
Assessment of the effect of the combined treatment on the quality of life
2 years
Study Arms (2)
Chemoradiotherapy
OTHERstandard of care chemo-radiotherapy
Combination
EXPERIMENTALstandard of care chemo-radiotherapy + Nivolumab
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven, muscle-invasive carcinoma of the bladder, cT2-T4aN0M0
- 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
You may not qualify if:
- Histology other than transitional-cell, squamous or adenocarcinoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hellenic GenitoUrinary Cancer Group
Athens, Attica, 11527, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 20, 2019
Study Start
May 28, 2019
Primary Completion
August 1, 2022
Study Completion
December 1, 2023
Last Updated
March 23, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share