CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 901
- Conditions
- ntreated Unresectable or Metastatic Urothelial CancerMedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501784-40-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1777
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
Patients with ECOG PS >= 2, 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, Participants may not have received live/attenuated vaccines within 30 days prior to first study treatment.
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