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 sites306 target enrollmentJanuary 26, 2015

Conditionsmetastatic or unresectable urothelial cancer MedDRA version: 18.0Level: LLTClassification code 10046723Term: Urothelial carcinoma ureterSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: 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: Not Applicable
Intervention: Not specified
Conditions: metastatic or unresectable urothelial cancer
Sponsor: Bristol-Myers Squibb International Corporation
Enrollment: 306
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 26, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb International Corporation

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)Any serious or uncontrolled medical disorder, that in the opinion of the investigator, may increase the risk
•associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or
•interfere with the interpretation of study results.
•c. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
•d. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
•e. 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. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
•f. Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or immune checkpoint pathways.
•g.Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.
•Exclusion laboratory criteria: