A study of Nivolumab combined with Ipilimumab or Standard of Care chemotherapy, versus standard of care chemotherapy in patients with previously untreated unresectable or metastatic urothelial cancer.
- Conditions
- ntreated Unresectable or Metastatic Urothelial CancerMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003881-14-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1360
- Metastatic or inoperable urothelial cancer
- Must have at least 1 lesion with measurable disease
- Must have full activity or, if limited, must be able to walk and carry out
light activities such as light house work or office work
- No prior systemic chemotherapy treatment in the metastatic setting
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1156
- Patients with disease that is suitable for local therapy administered
with curative intent
- Patients with active brain metastases or leptomeningeal metastases
- Patients with active, known or suspected autoimmune disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method