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)
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|ClinicalTrials.gov Identifier: NCT02632409|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Various Advanced Cancer||Biological: Nivolumab Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||February 11, 2016|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 27, 2026|
Nivolumab dose as specified
Placebo Comparator: Placebo
Placebo dose as specified
- Disease free survival (DFS) [ Time Frame: Approximately 5 years after the first subject is randomized ]DFS defined as the time between the date of randomization and the date of first recurrence or death (of any cause) whichever occurs first.
- Overall survival (OS) [ Time Frame: Approximately 5 years after the first subject is randomized ]OS is defined as the time between the date of randomization and the date of death (of any cause).
- Non-Urothelial track recurrence free survival (NUTRFS) [ Time Frame: Approximately 5 years after the first subject is randomized ]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.
- Disease specific survival (DSS) [ Time Frame: Approximately 5 years after the first subject is randomized ]DSS is defined as the time between the date of randomization and the date of death due to disease (urothelial cancer).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632409
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|