A study of nivolumab in participants with metastatic or unresectable bladder cancer

Conditions: metastatic or unresectable urothelial cancer
MedDRA version: 18.1Level: LLTClassification code 10046723Term: Urothelial carcinoma ureterSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: LLTClassification code 10046728Term: Urothelial carcinoma urethraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-003625-17-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 306

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153

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 costimulation 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:
-Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To measure the effect of nivolumab (BMS-<br>936558) in reducing tumor size in subjects with metastatic or<br>unresectable bladder cancer.;Secondary Objective: To measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.;Primary end point(s): The overall response rate (using RECIST 1.1) to nivolumab (BMS-936558) based on a independent review committee in subjects with metastatic or unresectable bladder cancer;Timepoint(s) of evaluation of this end point: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug is discontinued

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate progression free survival (using RECIST 1.1) in subjects based on assessments by an independent review committee<br>To evaluate overall survival in subjects as assessed by the investigator<br>To estimate overall response rate (using RECIST 1.1) in subjects as assessed by the investigator;Timepoint(s) of evaluation of this end point: Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued.<br>Every 3 months during the survival follow-up phase up to a maximum of 5 years<br>Eight weeks after the subject's first dose and then every 8 weeks after up to 48 weeks, then every 12 weeks until disease progression or study drug discontinued<br>

Related Trials