A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Various Advanced Cancer

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02387996

CA209-275

Details and patient eligibility

About

The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.

Enrollment

270 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis
Measurable disease by CT or MRI
Progression or recurrence after treatment
i) With at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or
ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion criteria

Subjects with active cancer that has spread to the central nervous system
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Subject with active, known or suspected autoimmune disease
Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

Exclusion laboratory criteria:

Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Known history of testing positive for human Immunodeficiency virus (HIV) or known acquired Immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply