Description:
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.
Title
- Brief Title: 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
- Official Title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
Clinical Trial IDs
- ORG STUDY ID:
CA209-274
- SECONDARY ID:
2014-003626-40
- NCT ID:
NCT02632409
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Nivolumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab | Experimental | Nivolumab dose as specified | |
Placebo | Placebo Comparator | Placebo dose as specified | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease free survival (DFS) |
Time Frame: | Approximately 5 years after the first subject is randomized |
Safety Issue: | |
Description: | DFS defined as the time between the date of randomization and the date of first recurrence or death (of any cause) whichever occurs first. |
Secondary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Approximately 5 years after the first subject is randomized |
Safety Issue: | |
Description: | OS is defined as the time between the date of randomization and the date of death (of any cause). |
Measure: | Non-Urothelial track recurrence free survival (NUTRFS) |
Time Frame: | Approximately 5 years after the first subject is randomized |
Safety Issue: | |
Description: | NUTRFS is defined as the time between the date of randomization and the date of first local non urothelial tract or distant recurrence or death (of any cause), whichever occurs first. |
Measure: | Disease specific survival (DSS) |
Time Frame: | Approximately 5 years after the first subject is randomized |
Safety Issue: | |
Description: | DSS is defined as the time between the date of randomization and the date of death due to disease (urothelial cancer). |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
September 10, 2020