History of Changes for Study: NCT02387996

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

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Study Record Versions

Version	Submitted Date	Changes
1	March 12, 2015	None (earliest Version on record)
2	March 20, 2015	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	April 10, 2015	Contacts/Locations and Study Status
4	April 20, 2015	Contacts/Locations and Study Status
5	May 6, 2015	Contacts/Locations and Study Status
6	May 20, 2015	Contacts/Locations and Study Status
7	June 3, 2015	Contacts/Locations and Study Status
8	June 22, 2015	Contacts/Locations and Study Status
9	July 3, 2015	Contacts/Locations and Study Status
10	July 17, 2015	Contacts/Locations and Study Status
11	August 6, 2015	Contacts/Locations and Study Status
12	August 19, 2015	Contacts/Locations and Study Status
13	September 3, 2015	Contacts/Locations and Study Status
14	September 16, 2015	Contacts/Locations and Study Status
15	September 30, 2015	Study Status and Eligibility
16	October 5, 2015	Contacts/Locations, Study Status and Study Design
17	October 15, 2015	Contacts/Locations and Study Status
18	November 4, 2015	Contacts/Locations and Study Status
19	November 18, 2015	Study Status and Contacts/Locations
20	December 8, 2015	Study Status
21	December 21, 2015	Study Status
22	January 6, 2016	Recruitment Status, Contacts/Locations and Study Status
23	January 8, 2016	Study Status
24	January 21, 2016	Study Status
25	January 26, 2016	Study Status
26	February 10, 2016	Study Status
27	February 25, 2016	Study Status
28	March 11, 2016	Contacts/Locations and Study Status
29	March 28, 2016	Contacts/Locations and Study Status
30	April 12, 2016	Contacts/Locations and Study Status
31	April 25, 2016	Study Status
32	May 11, 2016	Study Status
33	May 25, 2016	Study Status
34	June 9, 2016	Contacts/Locations and Study Status
35	June 24, 2016	Study Status
36	July 11, 2016	Study Status
37	July 26, 2016	Study Status
38	August 8, 2016	Study Status
39	August 23, 2016	Study Status
40	September 7, 2016	Study Status
41	September 23, 2016	Study Status
42	October 7, 2016	Study Status
43	October 26, 2016	Study Status
44	November 8, 2016	Study Status
45	November 30, 2016	Study Status
46	December 5, 2016	Study Status
47	December 6, 2016	Study Status
48	December 23, 2016	Study Status
49	January 5, 2017	Study Status
50	January 23, 2017	Study Status
51	January 27, 2017	Study Status
52	February 16, 2017	Study Status
53	March 3, 2017	Study Status
54	March 29, 2017	Study Status
55	May 19, 2017	Study Status, Outcome Measures, More Information, References, Study Design, Adverse Events, Baseline Characteristics, Participant Flow, Contacts/Locations and Oversight
56	July 7, 2017	Contacts/Locations and Study Status
57	October 9, 2017	Study Status and Contacts/Locations
58	January 19, 2018	Study Status
59	April 26, 2019	References, Contacts/Locations and Study Status
60	September 16, 2019	Contacts/Locations and Study Status
61	October 30, 2019	Study Status
62	July 6, 2020	Study Status and Contacts/Locations
63	March 17, 2022	Recruitment Status, Study Status, Contacts/Locations, References and Eligibility
64	October 11, 2022	Outcome Measures, Adverse Events, Participant Flow, Baseline Characteristics, References, Contacts/Locations, Study Status, More Information and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA209-275
Brief Title:	A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
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
Secondary IDs:

Study Status


Record Verification:	March 2015
Overall Status:	Not yet recruiting
Study Start:	March 2015
Primary Completion:	September 2016 [Anticipated]
Study Completion:	October 2017 [Anticipated]

First Submitted:	February 26, 2015
First Submitted that Met QC Criteria:	March 12, 2015
First Posted:	March 13, 2015 [Estimate]

Last Update Submitted that Met QC Criteria:	March 12, 2015
Last Update Posted:	March 13, 2015 [Estimate]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:	Ono Pharmaceutical Co. Ltd

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description


Brief Summary:	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.
Detailed Description:

Conditions


Conditions:	Various Advanced Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	250 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Nivolumab Nivolumab intravenous infusion as specified	Drug: Nivolumab Other Names: BMS(936558)

Outcome Measures


Primary Outcome Measures:
1.	Objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by independent review committee [ Time Frame: Up to 2 years ]
Secondary Outcome Measures:
1.	Progression free survival using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects based on assessments by an independent review committee [ Time Frame: Up to 5 years ]
2.	Overall survival in subjects as assessed by the investigator [ Time Frame: Up to 5 years ]
3.	Objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects as assessed by the investigator [ Time Frame: Up to 2 years ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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,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)

Contacts/Locations


Central Contact Person:	Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Email: Clinical.Trials@bms.com
Central Contact Backup:	First line of the email MUST contain NCT# and Site #.
Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:

IPDSharing


Plan to Share IPD:

References


Links:	URL: http://www.bms.com/studyconnect/Pages/home.aspx Description: BMS clinical trial educational resource
Available IPD/Information: