PMID- 31445199
OWN - NLM
STAT- MEDLINE
DCOM- 20200608
LR  - 20200608
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 119
DP  - 2019 Sep
TI  - Safety and efficacy of nivolumab in patients with rare melanoma subtypes who 
      progressed on or after ipilimumab treatment: a single-arm, open-label, phase II 
      study (CheckMate 172).
PG  - 168-178
LID - S0959-8049(19)30410-1 [pii]
LID - 10.1016/j.ejca.2019.07.010 [doi]
AB  - BACKGROUND: Nivolumab has been widely studied in non-acral cutaneous melanoma; 
      however, limited data are available in other melanoma subtypes. We report 
      outcomes by melanoma subtype in patients who received nivolumab after progression 
      on prior ipilimumab. PATIENTS AND METHODS: CheckMate 172 was a phase II, 
      single-arm, open-label, multicentre study that evaluated nivolumab in patients 
      with advanced melanoma who progressed on or after ipilimumab. Patients received 
      3 mg/kg of nivolumab, every 2 weeks for up to 2 years. The primary end-point was 
      incidence of grade >/=3, treatment-related select adverse events (AEs). RESULTS: 
      Among 1008 treated patients, we report data on patients with non-acral cutaneous 
      melanoma (n = 723 [71.7%]), ocular melanoma (n = 103 [10.2%]), mucosal melanoma 
      (n = 63 [6.3%]), acral cutaneous melanoma (n = 55 [5.5%]) and other melanoma 
      subtypes (n = 64 [6.3%]). There were no meaningful differences in the incidence 
      of grade >/=3, treatment-related select AEs among melanoma subtypes or compared 
      with the total population. No new safety signals emerged. At a minimum follow-up 
      of 18 months, median overall survival was 25.3 months for non-acral cutaneous 
      melanoma and 25.8 months for acral cutaneous melanoma, with 18-month overall 
      survival rates of 57.5% and 59.0%, respectively. Median overall survival was 12.6 
      months for ocular melanoma and 11.5 months for mucosal melanoma, with 18-month 
      overall survival rates of 34.8% and 31.5%, respectively. CONCLUSIONS: The safety 
      profile of nivolumab after ipilimumab is similar across melanoma subtypes. 
      Compared with non-acral cutaneous melanoma, patients with acral cutaneous 
      melanoma had similar survival outcomes, whereas those with ocular and mucosal 
      melanoma had lower median overall survival. CLINICALTRIALS. GOV ID: NCT02156804.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Nathan, Paul
AU  - Nathan P
AD  - Department of Medical Oncology, Mount Vernon Cancer Centre, London, United 
      Kingdom. Electronic address: p.nathan@nhs.net.
FAU - Ascierto, Paolo A
AU  - Ascierto PA
AD  - Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto 
      Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.
FAU - Haanen, John
AU  - Haanen J
AD  - Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, 
      Netherlands.
FAU - Espinosa, Enrique
AU  - Espinosa E
AD  - Department of Medical Oncology, Hospital Universitario La Paz, Universidad 
      Autonoma de Madrid, Madrid, Spain.
FAU - Demidov, Lev
AU  - Demidov L
AD  - N.N. Blokhin Russian Cancer Research Centre, Ministry of Health, Moscow, Russia.
FAU - Garbe, Claus
AU  - Garbe C
AD  - Division of Dermatologic Oncology, Department of Dermatology, Eberhard Karls 
      University, Tubingen, Germany.
FAU - Guida, Michele
AU  - Guida M
AD  - Department of Medical Oncology, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, 
      Italy.
FAU - Lorigan, Paul
AU  - Lorigan P
AD  - Institute of Cancer Sciences, University of Manchester, The Christie NHS 
      Foundation Trust, Manchester, UK.
FAU - Chiarion-Sileni, Vanna
AU  - Chiarion-Sileni V
AD  - Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
FAU - Gogas, Helen
AU  - Gogas H
AD  - First Department of Medicine, National and Kapodistrian University of Athens 
      School of Medicine, Laiko General Hospital, Athens, Greece.
FAU - Maio, Michele
AU  - Maio M
AD  - Division of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, 
      University Hospital of Siena, Siena, Italy.
FAU - Fierro, Maria Teresa
AU  - Fierro MT
AD  - Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, 
      Italy.
FAU - Hoeller, Christoph
AU  - Hoeller C
AD  - Department of Dermatology, Medical University of Vienna, Vienna, Austria.
FAU - Terheyden, Patrick
AU  - Terheyden P
AD  - Department of Dermatology, University of Lubeck, Lubeck, Germany.
FAU - Gutzmer, Ralf
AU  - Gutzmer R
AD  - Department of Dermatology, Hannover Medical School, Skin Cancer Centre Hannover, 
      Hannover, Germany.
FAU - Guren, Tormod K
AU  - Guren TK
AD  - Department of Oncology, Oslo University Hospital, Oslo, Norway.
FAU - Bafaloukos, Dimitrios
AU  - Bafaloukos D
AD  - Department of Oncology, Metropolitan Hospital, Athens, Greece.
FAU - Rutkowski, Piotr
AU  - Rutkowski P
AD  - Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie 
      Institute, Oncology Center, Warsaw, Poland.
FAU - Plummer, Ruth
AU  - Plummer R
AD  - Northern Institute for Cancer Research, Newcastle University, Newcastle Upon 
      Tyne, United Kingdom.
FAU - Waterston, Ashita
AU  - Waterston A
AD  - Clinical Trials Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK.
FAU - Kaatz, Martin
AU  - Kaatz M
AD  - Department of Dermatology, SRH Wald Clinics, University Hospital, Gera, Germany.
FAU - Mandala, Mario
AU  - Mandala M
AD  - Unit of Medical Oncology, Department of Oncology & Hematology, Papa Giovanni 
      XXIII Hospital, Bergamo, Italy.
FAU - Marquez-Rodas, Ivan
AU  - Marquez-Rodas I
AD  - Medical Oncology Department, General University Hospital Gregorio Maranon and 
      CIBERONC, Madrid, Spain.
FAU - Munoz-Couselo, Eva
AU  - Munoz-Couselo E
AD  - Medical Oncology, Vall D'Hebron University, Barcelona, Spain.
FAU - Dummer, Reinhard
AU  - Dummer R
AD  - Department of Dermatology, Universitats Spital, Zurich, Switzerland.
FAU - Grigoryeva, Elena
AU  - Grigoryeva E
AD  - Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Young, Tina C
AU  - Young TC
AD  - Global Biometric Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Schadendorf, Dirk
AU  - Schadendorf D
AD  - Department of Dermatology, University Hospital Essen, Essen, and the German 
      Cancer Consortium, Heidelberg, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02156804
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190821
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Ipilimumab)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Diarrhea/chemically induced
MH  - Disease Progression
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Ipilimumab/administration & dosage/adverse effects
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Melanoma/*drug therapy/pathology
MH  - Middle Aged
MH  - Nivolumab/administration & dosage/adverse effects
MH  - Skin Diseases/chemically induced
MH  - Skin Neoplasms/*drug therapy/pathology
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Acral
OT  - Advanced melanoma
OT  - Ipilimumab
OT  - Mucosal
OT  - Nivolumab
OT  - Ocular
EDAT- 2019/08/25 06:00
MHDA- 2020/06/09 06:00
CRDT- 2019/08/25 06:00
PHST- 2019/07/02 00:00 [received]
PHST- 2019/07/04 00:00 [accepted]
PHST- 2019/08/25 06:00 [pubmed]
PHST- 2020/06/09 06:00 [medline]
PHST- 2019/08/25 06:00 [entrez]
AID - S0959-8049(19)30410-1 [pii]
AID - 10.1016/j.ejca.2019.07.010 [doi]
PST - ppublish
SO  - Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 
      Aug 21.