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

Completed · Phase 4

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT02596035
Run by: Bristol-Myers Squibb
People needed: 197
Starts: 2016-01-08
Expected to finish: 2021-05-24
Last updated by the study team: 2022-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Other protocol-defined inclusion/exclusion criteria apply

Where it is running

Local Institution - 0030 — Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center — Bakersfield, California, United States
St. Jude Hospital Yorba Linda — Fullerton, California, United States
Cancer Care Associates Medical Group, Inc. — Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic — Santa Barbara, California, United States
University Of Colorado — Aurora, Colorado, United States
Local Institution - 0028 — Grand Junction, Colorado, United States
Local Institution - 0018 — Lakewood, Colorado, United States
Local Institution - 0008 — Fort Myers, Florida, United States
Baptist Health Medical Group Oncology — Miami, Florida, United States
Local Institution - 0007 — St. Petersburg, Florida, United States
Local Institution - 0054 — Tampa, Florida, United States
Illinois Cancer Specialists — Niles, Illinois, United States
Local Institution - 0052 — Fort Wayne, Indiana, United States
Norton Cancer Institute — Louisville, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
HCA Midwest Division — Kansas City, Missouri, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C. — Lincoln, Nebraska, United States
Local Institution - 0011 — Omaha, Nebraska, United States
Urology Cancer Center Laboratory — Omaha, Nebraska, United States
Local Institution - 0014 — Las Vegas, Nevada, United States
Local Institution - 0053 — Buffalo, New York, United States
Broome Oncology — Johnson City, New York, United States
Local Institution - 0055 — New York, New York, United States
Local Institution - 0001 — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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