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

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ClinicalTrials.gov Identifier: NCT02387996
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Results First Posted : May 24, 2017
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Various Advanced Cancer Drug: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
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 4, 2015
Actual Primary Completion Date : April 15, 2016
Estimated Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab intravenous infusion as specified
 Drug: Nivolumab
Other Name: BMS(936558)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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)
Contacts and Locations
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Information from the National Library of Medicine

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


  Show 67 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site
Investigator Inquiry Form  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02387996     History of Changes
Other Study ID Numbers: CA209-275
First Posted: March 13, 2015    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: February 15, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs