An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Various Advanced Cancer

Treatments: Biological: Nivolumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02632409

CA209-274

2014-003626-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Enrollment: 709 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
• Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
• Must have disease free status as determined by imaging within 4 weeks of dosing
• Tumor tissue must be provided for biomarker analysis
• Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Exclusion Criteria:

• Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
• Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
• Subjects with active, known or suspected autoimmune disease
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
• Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
• Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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709 participants in 2 patient groups, including a placebo group

Nivolumab

Experimental group

Description:

Nivolumab dose as specified

Treatment:

Biological: Nivolumab

Placebo

Placebo Comparator group

Description:

Placebo dose as specified

Treatment:

Other: Placebo