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)

Bristol-Myers Squibb187 sites in 6 countries709 target enrollmentMarch 22, 2016

ConditionsVarious Advanced Cancer

InterventionsNivolumab Placebo

Overview

Phase: Phase 3
Intervention: Nivolumab
Conditions: Various Advanced Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 709
Locations: 187
Primary Endpoint: Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 22, 2016

End Date

May 27, 2027

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Nivolumab

Nivolumab dose as specified

Intervention: Nivolumab

Placebo

Placebo dose as specified

Intervention: Placebo

Outcomes

Primary Outcomes

Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population

Time Frame: approximately up to 48 months

The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

Disease Free Survival (DFS)

Time Frame: approximately up to 48 months

Secondary Outcomes

Non-Urothelial Tract Recurrence Free Survival(up to 53 months)
Overall Survival in Participants With PD-L1 Expression ≥ 1%(on going)
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%(on going)
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population(up to 53 months)
Overall Survival(on going)
Disease Specific Survival(on going)