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

Phase 4

Completed

Conditions: Renal Cell Carcinoma

Interventions: Drug: Nivolumab

Registration Number: NCT02596035

Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 197

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab	Nivolumab	Nivolumab dose as specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)	Up to 100 days of the last dose of study drug (Approximately 2 years)	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

Name	Time	Method
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)	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	From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)	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)	Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)	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	Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)	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	From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)	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	Up to 100 days of the last dose of study drug (Approximately 2 years)	Percentage of participants with a resolution of IMAEs after initiating immune modulating medication.

Trial Locations

Locations (39): Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
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Baltimore, Maryland, United States
Local Institution - 0039
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Seattle, Washington, United States
Baptist Health Medical Group Oncology
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Miami, Florida, United States
Local Institution - 0034
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Houston, Texas, United States
Local Institution - 0004
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Nashville, Tennessee, United States
Local Institution - 0021
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San Antonio, Texas, United States
Local Institution - 0054
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Tampa, Florida, United States
Urology Cancer Center Laboratory
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Omaha, Nebraska, United States
University Of Colorado
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Aurora, Colorado, United States
Local Institution - 0011
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Omaha, Nebraska, United States
Local Institution - 0016
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Portland, Oregon, United States
Local Institution - 0030
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Phoenix, Arizona, United States
Cancer Care Associates Medical Group, Inc.
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Redondo Beach, California, United States
Comprehensive Blood And Cancer Center
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Bakersfield, California, United States
St. Jude Hospital Yorba Linda
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Fullerton, California, United States
Local Institution - 0018
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Lakewood, Colorado, United States
Local Institution - 0028
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Grand Junction, Colorado, United States
Local Institution - 0007
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Saint Petersburg, Florida, United States
Illinois Cancer Specialists
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Niles, Illinois, United States
Local Institution - 0052
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Fort Wayne, Indiana, United States
Norton Cancer Institute
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Louisville, Kentucky, United States
HCA Midwest Division
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Kansas City, Missouri, United States
Local Institution - 0014
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Las Vegas, Nevada, United States
Local Institution - 0053
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Buffalo, New York, United States
Broome Oncology
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Johnson City, New York, United States
Local Institution - 0055
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New York, New York, United States
Local Institution - 0001
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Tulsa, Oklahoma, United States
Local Institution - 0020
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Charleston, South Carolina, United States
Local Institution - 0005
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Chattanooga, Tennessee, United States
Local Institution - 0012
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Germantown, Tennessee, United States
Local Institution - 0015
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Dallas, Texas, United States
The Center For Cancer And Blood Disorders
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Fort Worth, Texas, United States
Local Institution - 0032
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Norfolk, Virginia, United States
Texas Cancer Center - Sherman
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Sherman, Texas, United States
Local Institution - 0017
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Roanoke, Virginia, United States
Local Institution - 0047
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Richmond, Virginia, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
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Lincoln, Nebraska, United States
Sansum Santa Barbara Medical Foundation Clinic
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Santa Barbara, California, United States
Local Institution - 0008
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Fort Myers, Florida, United States