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

Phase 3

Active, not recruiting

• Conditions: Various Advanced Cancer

• Registration Number: NCT02632409
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Study Start: 2016-03-22
• Primary Completion: 2020-07-17
• Results First Submitted: 2021-07-16
• Results First Submitted QC: 2021-11-05
• Results First Posted: 2021-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-08
• Study Completion: 2027-05-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 709

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population	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)	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.

Secondary Outcome Measures

Name	Time	Method
Non-Urothelial Tract Recurrence Free Survival	up to 53 months	The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Overall Survival in Participants With PD-L1 Expression ≥ 1%	on going	the time from randomization to the date of death from any cause.
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%	on going	the time from randomization to the date of death due to disease (urothelial cancer).
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population	up to 53 months	The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Overall Survival	on going	the time from randomization to the date of death from any cause.
Disease Specific Survival	on going	the time from randomization to the date of death due to disease (urothelial cancer).

Trial Locations

Locations (187)

Alaska Urological Institute dba Alaska Clinical Research Center; 🇺🇸 Anchorage, Alaska, United States

Local Institution - 0179; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0061; 🇺🇸 Clovis, California, United States

Local Institution - 0172; 🇺🇸 Sacramento, California, United States

Local Institution - 0005; 🇺🇸 San Francisco, California, United States

Local Institution - 0178; 🇺🇸 Lakewood, Colorado, United States

Local Institution - 0167; 🇺🇸 Gainesville, Florida, United States

Local Institution - 0030; 🇺🇸 Miami Beach, Florida, United States

Local Institution - 0008; 🇺🇸 Tampa, Florida, United States

Local Institution - 0168; 🇺🇸 Maywood, Illinois, United States

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