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An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374)

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0030
  • Comprehensive Blood And Cancer Center
  • St. Jude Hospital Yorba Linda
  • Cancer Care Associates Medical Group, Inc.
  • Sansum Santa Barbara Medical Foundation Clinic
  • University Of Colorado
  • Local Institution - 0028
  • Local Institution - 0018
  • Local Institution - 0008
  • Baptist Health Medical Group Oncology
  • Local Institution - 0007
  • Local Institution - 0054
  • Illinois Cancer Specialists
  • Local Institution - 0052
  • Norton Cancer Institute
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • HCA Midwest Division
  • Southeast Nebraska Hematology & Oncology Consultants, P.C.
  • Local Institution - 0011
  • Urology Cancer Center Laboratory
  • Local Institution - 0014
  • Local Institution - 0053
  • Broome Oncology
  • Local Institution - 0055
  • Local Institution - 0001
  • Local Institution - 0016
  • Local Institution - 0020
  • Local Institution - 0005
  • Local Institution - 0012
  • Local Institution - 0004
  • Local Institution - 0015
  • The Center For Cancer And Blood Disorders
  • Local Institution - 0034
  • Local Institution - 0021
  • Texas Cancer Center - Sherman
  • Local Institution - 0032
  • Local Institution - 0047
  • Local Institution - 0017
  • Local Institution - 0039

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab

Arm Description

Nivolumab dose as specified

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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
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.
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.

Full Information

First Posted
November 2, 2015
Last Updated
October 25, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02596035
Brief Title
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
Acronym
CheckMate 374
Official Title
A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2016 (Actual)
Primary Completion Date
March 19, 2018 (Actual)
Study Completion Date
May 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab dose as specified
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Description
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.
Time Frame
Up to 100 days of the last dose of study drug (Approximately 2 years)
Secondary Outcome Measure Information:
Title
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Description
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.
Time Frame
Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
Title
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Description
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.
Time Frame
From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
Title
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Description
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Time Frame
Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Title
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Description
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Time Frame
Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Title
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Description
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil.
Time Frame
From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
Title
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Description
Percentage of participants with a resolution of IMAEs after initiating immune modulating medication.
Time Frame
Up to 100 days of the last dose of study drug (Approximately 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced or Metastatic renal cell carcinoma (RCC) Predominant clear cell histology: At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0030
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Comprehensive Blood And Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
St. Jude Hospital Yorba Linda
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc.
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Sansum Santa Barbara Medical Foundation Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0028
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Local Institution - 0018
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Local Institution - 0008
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Baptist Health Medical Group Oncology
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Local Institution - 0007
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution - 0054
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Local Institution - 0052
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Southeast Nebraska Hematology & Oncology Consultants, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Local Institution - 0011
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Urology Cancer Center Laboratory
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Local Institution - 0014
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Local Institution - 0053
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Broome Oncology
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Local Institution - 0055
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0001
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Local Institution - 0016
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2982
Country
United States
Facility Name
Local Institution - 0020
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution - 0005
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Local Institution - 0012
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Local Institution - 0004
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 0015
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Center For Cancer And Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Local Institution - 0034
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Local Institution - 0021
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Cancer Center - Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090-0504
Country
United States
Facility Name
Local Institution - 0032
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Local Institution - 0047
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Local Institution - 0017
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Local Institution - 0039
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma

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