A study of nivolumab in participants with metastatic or unresectable bladder cancer

A phase II single arm clinical trial of nivolumab (BMS-936558) in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003625-17-DE

Enrollment

323

Registered

2014-12-11

Start date

2015-01-27

Completion date

Unknown

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic or unresectable urothelial cancer MedDRA version: 20.0 Level: LLT Classification code 10046723 Term: Urothelial carcinoma ureter System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10046714 Term: Urothelial carcinoma bladder System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10064467 Te

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder, urethra, ureter, or renal pelvis. b. Measurable disease by CT or MRI c. 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 platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer. d)Subjects that have received more than 2 prior lines of chemotherapy must not have liver metastases. e) tumor tissue (archived or new biopsy) must be provided for biomarker analysis f) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 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 161 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 162

Exclusion criteria

Exclusion criteria: a.Subjects with active cancer that has spread to the central nervous system. b.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured. c.Subjects with active, known or suspected autoimmune disease. d.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. e.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-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 sAg) 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.;Secondary Objective: -To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee -To evaluate overall survival in subjects as assessed by the investigator -To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator;Primary end point(s): The overall response rate (using RECIST 1.1) to nivolumab (BMS-936558) based on a independent review committee in subjects with metastatic or unresectable bladder cancer;Timepoint(s) of evaluation of this end point: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug is discontinued	—

Measure

Time frame

Main Objective: The purpose of the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.;Secondary Objective: -To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee -To evaluate overall survival in subjects as assessed by the investigator -To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator;Primary end point(s): The overall response rate (using RECIST 1.1) to nivolumab (BMS-936558) based on a independent review committee in subjects with metastatic or unresectable bladder cancer;Timepoint(s) of evaluation of this end point: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug is discontinued

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Secondary

Measure	Time frame
Secondary end point(s): -To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee -To evaluate overall survival in subjects as assessed by the investigator -To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator;Timepoint(s) of evaluation of this end point: -For progression free survival: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued. -For overall survival: Every 3 months during the survival follow-up phase up to a maximum of 5 years -for overall response rate: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued	—

Measure

Time frame

Secondary end point(s): -To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee -To evaluate overall survival in subjects as assessed by the investigator -To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator;Timepoint(s) of evaluation of this end point: -For progression free survival: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued. -For overall survival: Every 3 months during the survival follow-up phase up to a maximum of 5 years -for overall response rate: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued

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Countries

Australia, Belgium, Czech Republic, Finland, Germany, Italy, Japan, Poland, Spain, Sweden, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026