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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02387996




Registration number
NCT02387996
Ethics application status
Date submitted
26/02/2015
Date registered
13/03/2015
Date last updated
8/07/2020

Titles & IDs
Public title
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
Scientific 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 ID [1] 0 0
CA209-275
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Various Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab

Experimental: Nivolumab - Nivolumab intravenous infusion as specified


Treatment: Drugs: Nivolumab


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate Per BIRC Assessment - 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
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
ORR Per BIRC Assessment by PD-L1 Expression Level - 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
Timepoint [2] 0 0
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)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) Per BIRC Assessment - 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
Timepoint [1] 0 0
from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)
Secondary outcome [2] 0 0
PFS Per BIRC Assessment by PD-L1 Expression Level - 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
Timepoint [2] 0 0
from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)
Secondary outcome [3] 0 0
Overall Survival - 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.
Timepoint [3] 0 0
From first dosing date to the date of death (assessed up to 14 months)
Secondary outcome [4] 0 0
OS by PD-L1 Expression Level - 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
Timepoint [4] 0 0
From first dosing date to the date of death (approximately 14 months)
Secondary outcome [5] 0 0
Objective Response Rate (ORR) Per Investigator - 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.
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
ORR Per Investigator by PD-L1 Expression Level - 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
Timepoint [6] 0 0
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)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Local Institution - Waratah
Recruitment hospital [2] 0 0
Local Institution - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussels
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Hasselt
Country [20] 0 0
Czechia
State/province [20] 0 0
Brno
Country [21] 0 0
Czechia
State/province [21] 0 0
Olomouc
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 5
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
Finland
State/province [24] 0 0
Tampere
Country [25] 0 0
Germany
State/province [25] 0 0
Erfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Erlangen
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Heidelberg
Country [29] 0 0
Germany
State/province [29] 0 0
Jena
Country [30] 0 0
Germany
State/province [30] 0 0
Muenchen
Country [31] 0 0
Germany
State/province [31] 0 0
Rostock
Country [32] 0 0
Germany
State/province [32] 0 0
Tuebingen
Country [33] 0 0
Italy
State/province [33] 0 0
Arezzo
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Napoli
Country [36] 0 0
Italy
State/province [36] 0 0
Pavia
Country [37] 0 0
Italy
State/province [37] 0 0
Roma
Country [38] 0 0
Japan
State/province [38] 0 0
Akita
Country [39] 0 0
Japan
State/province [39] 0 0
Aomori
Country [40] 0 0
Japan
State/province [40] 0 0
Iwate
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Kumamoto
Country [43] 0 0
Japan
State/province [43] 0 0
Kyoto
Country [44] 0 0
Japan
State/province [44] 0 0
Niigata
Country [45] 0 0
Japan
State/province [45] 0 0
Osaka
Country [46] 0 0
Japan
State/province [46] 0 0
Tokyo
Country [47] 0 0
Japan
State/province [47] 0 0
Tsukuba-shi
Country [48] 0 0
Poland
State/province [48] 0 0
Gdansk
Country [49] 0 0
Poland
State/province [49] 0 0
Krakow
Country [50] 0 0
Poland
State/province [50] 0 0
Lodz
Country [51] 0 0
Poland
State/province [51] 0 0
Szczecin
Country [52] 0 0
Poland
State/province [52] 0 0
Wroclaw
Country [53] 0 0
Spain
State/province [53] 0 0
Badalona-barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Hospitalet de Llobregat - Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla
Country [58] 0 0
Sweden
State/province [58] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02387996
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications