An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, ... | Recruiting
An Investigational Immuno-therapy S... | Recruiting
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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Medical Conditions
  • Various Advanced Cancer
Primary Contact Details
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Recruitment Status
Recruiting
Trial source and source ID number
NCT02632409
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Biological : Nivolumab, Other : Placebo

Study Arm Groups : Nivolumab, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Disease free survival (DFS); Approximately 5 years after the first subject is randomized
Secondary Outcome Measures
    Non-Urothelial track recurrence free survival (NUTRFS); Approximately 5 years after the first subject is randomized; Disease specific survival (DSS); Approximately 5 years after the first subject is randomized; Overall survival (OS); Approximately 5 years after the first subject is randomized
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
640
Participant Inclusion 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 90 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 kidney removal (eg, partial cystectomy)

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
NW3 2QG
Manchester
M20 4BX
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Guy's Hospital
London
SE1 9RT
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Sheffield
S10 2SJ
Velindre NHS Trust
Cardiff
CF142TL
Trial Contact(s)
Primary Trial Contact
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Other Trial Contacts
First line of the email MUST contain NCT# and Site #.
Countries Recruiting
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
  • Ono Pharmaceutical Co. Ltd
Other Study ID Numbers
CA209-274
Sponsor(s)
Bristol-Myers Squibb
Key Dates

Recruitment Start Date

Feb 2016

Recruitment End Date

Apr 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

14 Dec 2015

Date updated in source

03 Nov 2017