Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015
Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial.
2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 572 papers, 7 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
572citing papers in PubMed, 7 pooled it
–field-weighted citation impact
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
NCT03233152 phase1 / phase2active not recruitingnot on this mapstarted 2016, after this paper: background citation
A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma
Biomarkers For Immune Checkpoint Inhibitors
Who cites it
572 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Integrating clinical trial landscapes and bibliometric analysis: unveiling the impact of PD-1/PD-L1 inhibitors on renal cell carcinoma research and therapeutic trajectories summary.Frontiers in immunology · 2025Pooled it
- Immune checkpoint inhibition for pancreatic ductal adenocarcinoma: limitations and prospects: a systematic review.Cell communication and signaling : CCS · 2021Pooled it
- Systematic review of combinations of targeted or immunotherapy in advanced solid tumors.Journal for immunotherapy of cancer · 2021Pooled it
- Treatment beyond progression with anti-PD-1/PD-L1 based regimens in advanced solid tumors: a systematic review.BMC cancer · 2021Pooled it
- Pooled it
- Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2021Pooled it
- Treatment-Related Serious Adverse Events of Immune Checkpoint Inhibitors in Clinical Trials: A Systematic Review.Frontiers in oncology · 2021Pooled it
- Exposure-response relationship of nivolumab and ipilimumab in patients with metastatic renal cell carcinoma from the randomised phase 2 BIONIKK study.British journal of cancer · 2026Trial
- Inosine enhances the efficacy of immune-checkpoint inhibitors in advanced solid tumors: A randomized, controlled, Phase 2 study.Cancer medicine · 2024Trial
- A phase II study of retifanlimab, a humanized anti-PD-1 monoclonal antibody, in patients with solid tumors (POD1UM-203).ESMO open · 2024Trial
- A phase II single arm study of Nivolumab with stereotactic Ablative radiation Therapy after induction chemotherapy in CHOlangiocarcinoma (NATCHO).BMC cancer · 2022Trial
- A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose Deescalation.Journal of clinical pharmacology · 2022Trial
- A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and Pembrolizumab Combination Therapy in Patients with Advanced Renal Cell Carcinoma.Clinical genitourinary cancer · 2021Trial
- Trial
- Integrative molecular characterization of sarcomatoid and rhabdoid renal cell carcinoma.Nature communications · 2021Trial
- Distinct endogenous retroviruses are expressed in mutational subtypes of clear cell renal cell carcinoma and are linked to improved clinical outcomes.Cell reports · 2026Article
- Combination Immunotherapy as a Promising Strategy to Overcome Immunotherapy Resistance: From Emergence to Next-Generation Approaches.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Immunogenic Cell Death: Unlocking New Frontiers in Cancer Immunotherapy.Cancer innovation · 2026Review
- Long-term survival with nivolumab in a patient with renal cell carcinoma: a case report and review of the literature.Journal of medical case reports · 2026Review
512 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Robert J MotzerRobert 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. motzerr@mskcc.org.
Brian I RiniRobert 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.
David F McDermottRobert 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.
Bruce G RedmanRobert 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.
Timothy M KuzelRobert 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.
Michael R HarrisonRobert 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.
Ulka N VaishampayanRobert 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.
Harry A DrabkinRobert 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.
Saby GeorgeRobert 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.
Theodore F LoganRobert 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.
Kim A MargolinRobert 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.
Elizabeth R PlimackRobert 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.
Alexandre M LambertRobert 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.
Ian M WaxmanRobert 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.
Hans J HammersRobert 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.
Funding
X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4MWomen's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI DONNA NIEDZWIECKI · 1985 to 2026
$174.8MTumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Daniela E Matei · 1993 to 2026
$153.9MTumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4MNCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014236NCI NIH HHS P30 CA022453NCI NIH HHS P30 CA060553
Abstract
purposeNivolumab 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 AND
methodsPatients 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.
resultsA 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.
conclusionNivolumab 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.
Indexed as
Administration, IntravenousAgedAntibodies, MonoclonalAntineoplastic AgentsB7-H1 AntigenCanadaCarcinoma, Renal CellDisease-Free SurvivalDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleFemaleFinlandHumansItalyKaplan-Meier EstimateAntibodies, MonoclonalAntineoplastic AgentsB7-H1 AntigenCD274 protein, humanNivolumab
Identifiers
What OpenQuestion holds
Textmetadata
LicenceTDM
Read underepoch 390
Registered trials
NCT03233152ClinicalTrials.gov
NCT04204434ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.