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PMID: 25452452 Published · ppublish English Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology ·Vol. 33 ·No. 13 ·2015-05-01 ·Pages 1430-7

Motzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, Vaishampayan UN, Drabkin HA, George S, Logan TF, Margolin KA, Plimack ER, Lambert AM, Waxman IM, Hammers HJ

Abstract

Nivolumab is a fully human immunoglobulin G4 programmed death-1 immune checkpoint inhibitor antibody that restores T-cell immune activity. This phase II trial assessed the antitumor activity, dose-response relationship, and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC). Patients with clear-cell mRCC previously treated with agents targeting the vascular endothelial growth factor pathway were randomly assigned (blinded ratio of 1:1:1) to nivolumab 0.3, 2, or 10 mg/kg intravenously once every 3 weeks. The primary objective was to evaluate the dose-response relationship as measured by progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), and safety. A total of 168 patients were randomly assigned to the nivolumab 0.3- (n = 60), 2- (n = 54), and 10-mg/kg (n = 54) cohorts. One hundred eighteen patients (70%) had received more than one prior systemic regimen. Median PFS was 2.7, 4.0, and 4.2 months, respectively (P = .9). Respective ORRs were 20%, 22%, and 20%. Median OS was 18.2 months (80% CI, 16.2 to 24.0 months), 25.5 months (80% CI, 19.8 to 28.8 months), and 24.7 months (80% CI, 15.3 to 26.0 months), respectively. The most common treatment-related adverse event (AE) was fatigue (24%, 22%, and 35%, respectively). Nineteen patients (11%) experienced grade 3 to 4 treatment-related AEs. Nivolumab demonstrated antitumor activity with a manageable safety profile across the three doses studied in mRCC. No dose-response relationship was detected as measured by PFS. These efficacy and safety results in mRCC support study in the phase III setting.

MeSH Terms
Administration, Intravenous Aged Antibodies, Monoclonal/administration & dosage,adverse effects,therapeutic use Antineoplastic Agents/administration & dosage,adverse effects,therapeutic use B7-H1 Antigen/antagonists & inhibitors Canada Carcinoma, Renal Cell/drug therapy,immunology,mortality,secondary Disease Progression Disease-Free Survival Dose-Response Relationship, Drug Drug Administration Schedule Female Finland Humans Italy Kaplan-Meier Estimate Kidney Neoplasms/drug therapy,immunology,mortality,pathology Male Middle Aged Nivolumab Proportional Hazards Models Time Factors Treatment Outcome United States
Chemicals
Antibodies, Monoclonal Antineoplastic Agents B7-H1 Antigen CD274 protein, human Nivolumab
Authors & Affiliations
15 authors, click to expand affiliations / ORCID
Motzer Robert J
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD. [email protected].
Rini Brian I
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
McDermott David F
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Redman Bruce G
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Kuzel Timothy M
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Harrison Michael R
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Vaishampayan Ulka N
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Drabkin Harry A
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
George Saby
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Logan Theodore F
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Margolin Kim A
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Plimack Elizabeth R
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Lambert Alexandre M
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Waxman Ian M
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
Hammers Hans J
Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York; Saby George, Roswell Park Cancer Institute, Buffalo, NY; Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; David F. McDermott, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA; Bruce G. Redman, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ulka N. Vaishampayan, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Timothy M. Kuzel, Northwestern University Feinberg School of Medicine, Chicago, IL; Michael R. Harrison, Duke University Medical Center, Durham, NC; Harry A. Drabkin, Medical University of South Carolina, Charleston, SC; Theodore F. Logan, Indiana University Simon Cancer Center, Indianapolis, IN; Kim A. Margolin, Stanford University, Stanford, CA; Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Alexandre M. Lambert, Bristol-Myers Squibb, Braine-l'Alleud, Belgium; Ian M. Waxman, Bristol-Myers Squibb, Princeton, NJ; and Hans J. Hammers, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.
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Article Info
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Abbr.
J Clin Oncol
ISSN
1527-7755
DOI
10.1200/JCO.2014.59.0703
Email
[email protected]
Published
2015-05-01
Epub
2014-00-01
Pages
1430-7
Language
English
Region
United States
NLM ID
8309333
PMCID
PMC4806782
Subset
IM
Grants
NCI NIH HHS · P30 CA008748 · United States
NCI NIH HHS · P30 CA014236 · United States
NCI NIH HHS · P30 CA022453 · United States
NCI NIH HHS · P30 CA060553 · United States
Databases
ClinicalTrials.gov
NCT01354431
External Links
PubMed source DOI: 10.1200/JCO.2014.59.0703 PMC Full Text View journal details
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