PMID- 28915085 OWN - NLM STAT- MEDLINE DCOM- 20171211 LR - 20220408 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 35 IP - 34 DP - 2017 Dec 1 TI - Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma. PG - 3815-3822 LID - 10.1200/JCO.2016.72.1167 [doi] AB - Purpose The addition of nivolumab (anti-programmed death-1 antibody) to ipilimumab (anti-cytotoxic T-cell lymphocyte-associated 4 antibody) in patients with advanced melanoma improves antitumor response and progression-free survival but with a higher frequency of adverse events (AEs). This cross-melanoma study describes the safety profile of the approved nivolumab plus ipilimumab regimen. Methods This retrospective safety review on data from three trials (phase I, II, and III) included patients with advanced melanoma who received at least one dose of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks x 4 and then nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity while following established guidelines for AE management. Analyses were of all treatment-related AEs, select (immune-related) AEs, time to onset and resolution, and use of immune-modulating agents and their effects on outcome. Results Among 448 patients, median duration of follow-up was 13.2 months. Treatment-related grade 3/4 AEs occurred in 55.5% of patients; 35.7% had treatment-related AEs that led to discontinuation. The most frequent treatment-related select AEs of any grade were skin (64.3%) and GI (46.7%) and of grade 3/4, hepatic (17.0%) and GI (16.3%); 30.1% developed a grade 2 to 4 select AE in more than one organ category. Median time to onset of grade 3/4 treatment-related select AEs ranged from 3.1 (skin) to 16.3 (renal) weeks, and with the exclusion of endocrine AEs, median time to resolution from onset ranged from 1.9 (renal) to 4.5 (pulmonary) weeks, with resolution rates between 79% and 100% while using immune-modulating agents. Four (< 1%) on-study deaths were attributed to therapy. Conclusion Frequency of grade 3/4 treatment-related AEs was higher with nivolumab plus ipilimumab and occurred earlier than historical experience with either agent alone, but resolution rates were similar. FAU - Sznol, Mario AU - Sznol M AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Ferrucci, Pier Francesco AU - Ferrucci PF AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Hogg, David AU - Hogg D AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Atkins, Michael B AU - Atkins MB AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Wolter, Pascal AU - Wolter P AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Guidoboni, Massimo AU - Guidoboni M AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Lebbe, Celeste AU - Lebbe C AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Kirkwood, John M AU - Kirkwood JM AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Schachter, Jacob AU - Schachter J AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Daniels, Gregory A AU - Daniels GA AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Hassel, Jessica AU - Hassel J AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Cebon, Jonathan AU - Cebon J AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Gerritsen, Winald AU - Gerritsen W AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Atkinson, Victoria AU - Atkinson V AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Thomas, Luc AU - Thomas L AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - McCaffrey, John AU - McCaffrey J AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Power, Derek AU - Power D AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Walker, Dana AU - Walker D AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Bhore, Rafia AU - Bhore R AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Jiang, Joel AU - Jiang J AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Hodi, F Stephen AU - Hodi FS AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Wolchok, Jedd D AU - Wolchok JD AD - Mario Sznol, Yale Comprehensive Cancer Center, New Haven, CT; Pier Francesco Ferrucci, Istituto Europeo di Oncologia, Milan; Massimo Guidoboni, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; David Hogg, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Michael B. Atkins, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Celeste Lebbe, Universite Paris Diderot, Paris; Luc Thomas, Centre Hospitalier Lyon-Sud, Pierre-Benite, France; John M. Kirkwood, Hillman Cancer Center, Pittsburgh, PA; Jacob Schachter, Sheba Medical Center, Ramat Gan, Israel; Gregory A. Daniels, University of California San Diego, Moores Cancer Center, La Jolla, CA; Jessica Hassel, University Hospital, Heidelberg, Germany; Jonathan Cebon, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria; Winald Gerritsen, University of Queensland, St Lucia; Victoria Atkinson, Gallipoli Medical Research Foundation, Greenslopes; Victoria Atkinson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; Winald Gerritsen, Radboud University Medical Center, Nijmegen, the Netherlands; John McCaffrey, Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland; Dana Walker, Rafia Bhore, and Joel Jiang, Bristol-Myers Squibb, Princeton, NJ; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; and Jedd D. Wolchok, Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY. LA - eng PT - Evaluation Study PT - Journal Article DEP - 20170915 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal) RN - 0 (Ipilimumab) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Adult MH - Aged MH - Antibodies, Monoclonal/*administration & dosage/adverse effects MH - Clinical Trials, Phase I as Topic MH - Clinical Trials, Phase II as Topic MH - Clinical Trials, Phase III as Topic MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Female MH - Humans MH - Ipilimumab/*administration & dosage/adverse effects MH - Male MH - Maximum Tolerated Dose MH - Melanoma/*drug therapy/*mortality/parasitology MH - Middle Aged MH - Neoplasm Invasiveness/pathology MH - Neoplasm Staging MH - Nivolumab MH - Patient Safety MH - Prognosis MH - Randomized Controlled Trials as Topic MH - Retrospective Studies MH - Skin Neoplasms/*drug therapy/*mortality/pathology MH - Survival Analysis EDAT- 2017/09/16 06:00 MHDA- 2017/12/12 06:00 CRDT- 2017/09/16 06:00 PHST- 2017/09/16 06:00 [pubmed] PHST- 2017/12/12 06:00 [medline] PHST- 2017/09/16 06:00 [entrez] AID - 10.1200/JCO.2016.72.1167 [doi] PST - ppublish SO - J Clin Oncol. 2017 Dec 1;35(34):3815-3822. doi: 10.1200/JCO.2016.72.1167. Epub 2017 Sep 15.