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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:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02387996
First received: February 26, 2015
Last updated: March 29, 2017
Last verified: May 2016
  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: No masking
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 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:
  • 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 ]
  • Overall survival in subjects as assessed by the investigator [ Time Frame: Up to 5 years ]
  • 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 ]

Estimated Enrollment: 242
Study Start Date: March 2015
Estimated Study Completion Date: October 2018
Primary Completion Date: April 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 26, 2015
Last Updated: March 29, 2017

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

ClinicalTrials.gov processed this record on April 28, 2017