PMID- 31581055
OWN - NLM
STAT- MEDLINE
DCOM- 20200608
LR  - 20200608
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 121
DP  - 2019 Nov
TI  - Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma 
      who progressed on or after ipilimumab treatment: A single-arm, open-label, phase 
      II study (CheckMate 172).
PG  - 144-153
LID - S0959-8049(19)30474-5 [pii]
LID - 10.1016/j.ejca.2019.08.014 [doi]
AB  - BACKGROUND: Limited data are available on nivolumab in challenging subgroups with 
      advanced melanoma. We report outcomes of nivolumab after prior ipilimumab in 
      patients who are typically excluded from clinical trials. PATIENTS AND METHODS: 
      In this phase II, single-arm, open-label, multicentre study (CheckMate 172), 
      patients with advanced melanoma who progressed on or after ipilimumab received 
      nivolumab 3 mg/kg, every 2 weeks for up to 2 years. The primary objective was 
      incidence of grade >/=3, treatment-related select adverse events (AEs). RESULTS: At 
      a minimum follow-up of 18 months, grade >/=3 treatment-related select AEs with the 
      most variation across subgroups were diarrhoea and colitis (1.1% [n = 11] and 
      0.3% [n = 3] for the total population [n = 1008]; 0.6% [n = 1] and 0.6% [n = 1] 
      for patients with an asymptomatic central nervous system [CNS] metastasis 
      [n = 165; 16.4%]; 4.5% [n = 3] and 3.0% [n = 2] for patients with an Eastern 
      Cooperative Oncology Group performance status [ECOG PS] of 2 [n = 66; 6.5%]; 2.4% 
      [n = 2] and 0% for those who experienced a grade 3/4 immune-related AE [irAE] 
      with prior ipilimumab [n = 84; 8.3%]; and 0% and 0% for autoimmune disease 
      [n = 25; 2.5%], respectively). Median overall survival was 21.4 months in the 
      total population and was 11.6, 2.4, 21.5, and 18.6 months in patients with a CNS 
      metastasis, ECOG PS 2, a grade 3/4 irAE with prior ipilimumab, and autoimmune 
      disease, respectively. CONCLUSIONS: In this large, phase II clinical trial of 
      patients with advanced melanoma who progressed on or after ipilimumab, nivolumab 
      demonstrated a safety profile consistent with that of prior clinical trials. 
      ClinicalTrials.gov ID: NCT02156804.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Schadendorf, Dirk
AU  - Schadendorf D
AD  - Department of Dermatology, University Hospital Essen, Essen, German Cancer 
      Consortium, Heidelberg, Germany. Electronic address: 
      Dirk.Schadendorf@uk-essen.de.
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, the 
      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 - Nathan, Paul
AU  - Nathan P
AD  - Department of Medical Oncology, Mount Vernon Cancer Centre, London, United 
      Kingdom.
LA  - eng
SI  - ClinicalTrials.gov/NCT02156804
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190930
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  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Disease Progression
MH  - Drug Resistance, Neoplasm/drug effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Ipilimumab/*therapeutic use
MH  - Male
MH  - Melanoma/*drug therapy/mortality/pathology
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Nivolumab/*therapeutic use
MH  - Skin Neoplasms/*drug therapy/mortality/pathology
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Advanced melanoma
OT  - Autoimmune
OT  - CNS metastasis
OT  - ECOG performance status
OT  - Ipilimumab
OT  - Nivolumab
EDAT- 2019/10/04 06:00
MHDA- 2020/06/09 06:00
CRDT- 2019/10/04 06:00
PHST- 2019/07/02 00:00 [received]
PHST- 2019/08/19 00:00 [revised]
PHST- 2019/08/22 00:00 [accepted]
PHST- 2019/10/04 06:00 [pubmed]
PHST- 2020/06/09 06:00 [medline]
PHST- 2019/10/04 06:00 [entrez]
AID - S0959-8049(19)30474-5 [pii]
AID - 10.1016/j.ejca.2019.08.014 [doi]
PST - ppublish
SO  - Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 
      Sep 30.