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

Launched by HELLENIC GENITOURINARY CANCER GROUP · Jun 18, 2019

Keywords

ClinConnect Summary

The initial hypothesis is that addition of nivolumab will increase 2-year locoregional control rate from 55% (control arm) to 75% (immunotherapy arm)

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 ...

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Eligibility criteria

• 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