CompletedPhase 2

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

United States270 participantsStarted 2015-03-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 targetin…

What they're measuring

Objective Response Rate Per BIRC Assessment

Timeframe: 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)

ORR Per BIRC Assessment by PD-L1 Expression Level

Timeframe: 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)

Time to Response (TTR)

Timeframe: From first dosing date to the date of the first confirmed response (up to approximately 14 months)

Duration of Response (DOR)

Timeframe: From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months)

Trial details

NCT IDNCT02387996

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04-15

Results submitted2017-04-13

View on ClinicalTrials.gov More Various Advanced Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Objective Response Rate Per BIRC Assessment

Timeframe: 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)

ORR Per BIRC Assessment by PD-L1 Expression Level

Timeframe: 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)

Time to Response (TTR)

Timeframe: From first dosing date to the date of the first confirmed response (up to approximately 14 months)

Duration of Response (DOR)

Timeframe: From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months)