Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
CheckMate 274
Clinical summary
Summary
The purpose of this study is to determine the efficacy and safety of nivolumab versus placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Conditions
This trial is treating people with urothelial cancer
Eligibility
Inclusion
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific Title
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma
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