A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
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ClinicalTrials.gov Identifier: NCT02387996 |
Recruitment Status :
Completed
First Posted : March 13, 2015
Results First Posted : May 24, 2017
Last Update Posted : March 31, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Various Advanced Cancer | Drug: Nivolumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 386 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | March 9, 2015 |
Actual Primary Completion Date : | April 15, 2016 |
Actual Study Completion Date : | November 12, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Nivolumab
Nivolumab intravenous infusion as specified
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Drug: Nivolumab
Other Name: BMS(936558) |
- Objective Response Rate Per BIRC Assessment [ Time Frame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) ]Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee
- ORR Per BIRC Assessment by PD-L1 Expression Level [ Time Frame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) ]Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category
- Progression-Free Survival (PFS) Per BIRC Assessment [ Time Frame: from first dosing date to the date of the first documented tumor progression (assessed up to 14 months) ]PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. RECIST = Response Evaluation Criteria in Solid Tumors
- PFS Per BIRC Assessment by PD-L1 Expression Level [ Time Frame: from first dosing date to the date of the first documented tumor progression (assessed up to 14 months) ]PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. RECIST is the Response Evaluation Criteria in Solid Tumors PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category
- Overall Survival [ Time Frame: From first dosing date to the date of death (assessed up to 14 months) ]Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive.
- OS by PD-L1 Expression Level [ Time Frame: From first dosing date to the date of death (approximately 14 months) ]Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive. PD-L1 expression level = membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category
- Objective Response Rate (ORR) Per Investigator [ Time Frame: from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) ]Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects.
- ORR Per Investigator by PD-L1 Expression Level [ Time Frame: from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) ]Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387996

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02387996 |
Other Study ID Numbers: |
CA209-275 |
First Posted: | March 13, 2015 Key Record Dates |
Results First Posted: | May 24, 2017 |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |