Clinical trial · Interventional
Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy
Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy: a Phase II, Randomized Study
NCT03993249CI-TRIAL-00057279unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiotherapy | Other | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Chemoradiotherapy
- description
- standard of care chemo-radiotherapy
- interventionNames
- Other: chemoradiotherapy
- type
- EXPERIMENTAL
- label
- Combination
- description
- standard of care chemo-radiotherapy + Nivolumab
- interventionNames
- Biological: Nivolumab
- Other: chemoradiotherapy
Primary outcomes (1)
- measure
- Locoregional control rate
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: Key Exclusion Criteria * 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
References
Publications (0)
Data not yet available
No reference posted for this study.