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

Renal Cell Carcinoma Clinical Trial

— 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)

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls