Clinical trial NCT02596035: An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
timeFrame: Up to 100 days of the last dose of study drug (Approximately 2 years)
Secondary outcomes:
measure: Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
timeFrame: Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
measure: Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
timeFrame: From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
measure: Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
timeFrame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
measure: Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
timeFrame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
measure: Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
timeFrame: From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
measure: Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
timeFrame: Up to 100 days of the last dose of study drug (Approximately 2 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0030
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood And Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Medical Foundation Clinic
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Grand Junction
country: United States
facility: Local Institution - 0028
state: Colorado
city: Lakewood
country: United States
facility: Local Institution - 0018
state: Colorado
city: Fort Myers
country: United States
facility: Local Institution - 0008
state: Florida
city: Miami
country: United States
facility: Baptist Health Medical Group Oncology
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0007
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0054
state: Florida
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 0052
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Kansas City
country: United States
facility: HCA Midwest Division
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.
state: Nebraska
city: Omaha
country: United States
facility: Local Institution - 0011
state: Nebraska
city: Omaha
country: United States
facility: Urology Cancer Center Laboratory
state: Nebraska
city: Las Vegas
country: United States
facility: Local Institution - 0014
state: Nevada
city: Buffalo
country: United States
facility: Local Institution - 0053
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: New York
country: United States
facility: Local Institution - 0055
state: New York
city: Tulsa
country: United States
facility: Local Institution - 0001
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 0016
state: Oregon
city: Charleston
country: United States
facility: Local Institution - 0020
state: South Carolina
city: Chattanooga
country: United States
facility: Local Institution - 0005
state: Tennessee
city: Germantown
country: United States
facility: Local Institution - 0012
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0004
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0015
state: Texas
city: Fort Worth
country: United States
facility: The Center For Cancer And Blood Disorders
state: Texas
city: Houston
country: United States
facility: Local Institution - 0034
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0021
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 0032
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 0047
state: Virginia
city: Roanoke
country: United States
facility: Local Institution - 0017
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 0039
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: