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Clinical Trials/EUCTR2014-003625-17-BE
EUCTR2014-003625-17-BE
Active, not recruiting
Phase 1

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

Bristol-Myers Squibb International Corporation0 sites323 target enrollmentJanuary 29, 2015
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Conditionsmetastatic or unresectable urothelial cancerMedDRA version: 20.0Level: LLTClassification code 10046723Term: Urothelial carcinoma ureterSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10046728Term: Urothelial carcinoma urethraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
metastatic or unresectable urothelial cancer
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
323
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 29, 2015
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •a. Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder, urethra, ureter, or renal pelvis.
  • •b. Measurable disease by CT or MRI
  • •c. 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 platinum agent in the setting of cystectomy for localized muscle\-invasive urothelial cancer.
  • •d)Subjects that have received more than 2 prior lines of chemotherapy must not have liver metastases.
  • •e) tumor tissue (archived or new biopsy) must be provided for biomarker analysis
  • •f) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •a.Subjects with active cancer that has spread to the central nervous system.
  • •b.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
  • •c.Subjects with active, known or suspected autoimmune disease.
  • •d.Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
  • •e.Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-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 sAg) 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).

Outcomes

Primary Outcomes

Not specified

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