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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02596035
Other study ID # CA209-374
Secondary ID 2015-003286-28
Status Completed
Phase Phase 4
First received
Last updated
Start date January 8, 2016
Est. completion date May 24, 2021

Study information

Verified date October 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date May 24, 2021
Est. primary completion date March 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Advanced or Metastatic renal cell carcinoma (RCC) - Predominant clear cell histology: 1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments 2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting 3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible - Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor - Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation - Performance Status (PS): = 70% Karnofsky Performance Scale (KPS) - All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed Exclusion Criteria: - Subjects with any active autoimmune disease or a history of known autoimmune disease - History of severe hypersensitivity reaction to other monoclonal antibodies - Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured - Known HIV or AIDS-related illness - Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab


Locations

Country Name City State
United States University Of Colorado Aurora Colorado
United States Comprehensive Blood And Cancer Center Bakersfield California
United States Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Baltimore Maryland
United States Local Institution - 0053 Buffalo New York
United States Local Institution - 0020 Charleston South Carolina
United States Local Institution - 0005 Chattanooga Tennessee
United States Local Institution - 0015 Dallas Texas
United States Local Institution - 0008 Fort Myers Florida
United States Local Institution - 0052 Fort Wayne Indiana
United States The Center For Cancer And Blood Disorders Fort Worth Texas
United States St. Jude Hospital Yorba Linda Fullerton California
United States Local Institution - 0012 Germantown Tennessee
United States Local Institution - 0028 Grand Junction Colorado
United States Local Institution - 0034 Houston Texas
United States Broome Oncology Johnson City New York
United States HCA Midwest Division Kansas City Missouri
United States Local Institution - 0018 Lakewood Colorado
United States Local Institution - 0014 Las Vegas Nevada
United States Southeast Nebraska Hematology & Oncology Consultants, P.C. Lincoln Nebraska
United States Norton Cancer Institute Louisville Kentucky
United States Baptist Health Medical Group Oncology Miami Florida
United States Local Institution - 0004 Nashville Tennessee
United States Local Institution - 0055 New York New York
United States Illinois Cancer Specialists Niles Illinois
United States Local Institution - 0032 Norfolk Virginia
United States Local Institution - 0011 Omaha Nebraska
United States Urology Cancer Center Laboratory Omaha Nebraska
United States Local Institution - 0030 Phoenix Arizona
United States Local Institution - 0016 Portland Oregon
United States Cancer Care Associates Medical Group, Inc. Redondo Beach California
United States Local Institution - 0047 Richmond Virginia
United States Local Institution - 0017 Roanoke Virginia
United States Local Institution - 0007 Saint Petersburg Florida
United States Local Institution - 0021 San Antonio Texas
United States Sansum Santa Barbara Medical Foundation Clinic Santa Barbara California
United States Local Institution - 0039 Seattle Washington
United States Texas Cancer Center - Sherman Sherman Texas
United States Local Institution - 0054 Tampa Florida
United States Local Institution - 0001 Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term. Up to 100 days of the last dose of study drug (Approximately 2 years)
Secondary Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date. Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
Secondary Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive. From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
Secondary Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade) Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Secondary Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Secondary Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil. From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
Secondary Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication Percentage of participants with a resolution of IMAEs after initiating immune modulating medication. Up to 100 days of the last dose of study drug (Approximately 2 years)
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