An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
CheckMate 374
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)
2 other identifiers
interventional
197
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2016
Longer than P75 for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedStudy Start
First participant enrolled
January 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2018
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2021
CompletedOctober 27, 2022
October 1, 2022
2.2 years
November 2, 2015
April 29, 2019
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
- +1 more secondary outcomes
Study Arms (1)
Nivolumab
EXPERIMENTALNivolumab dose as specified
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Local Institution - 0030
Phoenix, Arizona, 85016, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309, United States
St. Jude Hospital Yorba Linda
Fullerton, California, 92835, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Local Institution - 0028
Grand Junction, Colorado, 81501, United States
Local Institution - 0018
Lakewood, Colorado, 80228, United States
Local Institution - 0008
Fort Myers, Florida, 33901, United States
Baptist Health Medical Group Oncology
Miami, Florida, 33176, United States
Local Institution - 0007
St. Petersburg, Florida, 33705, United States
Local Institution - 0054
Tampa, Florida, 33612-9497, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Local Institution - 0052
Fort Wayne, Indiana, 46845, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231, United States
HCA Midwest Division
Kansas City, Missouri, 64132, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, 68510, United States
Local Institution - 0011
Omaha, Nebraska, 68130, United States
Urology Cancer Center Laboratory
Omaha, Nebraska, 68130, United States
Local Institution - 0014
Las Vegas, Nevada, 89169, United States
Local Institution - 0053
Buffalo, New York, 14263, United States
Broome Oncology
Johnson City, New York, 13790, United States
Local Institution - 0055
New York, New York, 10065, United States
Local Institution - 0001
Tulsa, Oklahoma, 74146, United States
Local Institution - 0016
Portland, Oregon, 97213-2982, United States
Local Institution - 0020
Charleston, South Carolina, 29414, United States
Local Institution - 0005
Chattanooga, Tennessee, 37404, United States
Local Institution - 0012
Germantown, Tennessee, 38138, United States
Local Institution - 0004
Nashville, Tennessee, 37203, United States
Local Institution - 0015
Dallas, Texas, 75246, United States
The Center For Cancer And Blood Disorders
Fort Worth, Texas, 76104, United States
Local Institution - 0034
Houston, Texas, 77024, United States
Local Institution - 0021
San Antonio, Texas, 78217, United States
Texas Cancer Center - Sherman
Sherman, Texas, 75090-0504, United States
Local Institution - 0032
Norfolk, Virginia, 23502, United States
Local Institution - 0047
Richmond, Virginia, 23230, United States
Local Institution - 0017
Roanoke, Virginia, 24014, United States
Local Institution - 0039
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 4, 2015
Study Start
January 8, 2016
Primary Completion
March 19, 2018
Study Completion
May 24, 2021
Last Updated
October 27, 2022
Results First Posted
August 28, 2019
Record last verified: 2022-10