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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02387996
First Posted: March 13, 2015
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Various Advanced Cancer Drug: Nivolumab Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 386
Actual Study Start Date: March 4, 2015
Estimated Study Completion Date: October 2, 2018
Primary Completion Date: April 15, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab
Nivolumab intravenous infusion as specified
Drug: Nivolumab
Other Name: BMS(936558)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02387996     History of Changes
Other Study ID Numbers: CA209-275
First Submitted: February 26, 2015
First Posted: March 13, 2015
Results First Submitted: April 13, 2017
Results First Posted: May 24, 2017
Last Update Posted: October 11, 2017
Last Verified: October 2017

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