PMID- 28031816
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210102
IS  - 2051-1426 (Electronic)
IS  - 2051-1426 (Linking)
VI  - 4
DP  - 2016
TI  - A phase IB study of ipilimumab with peginterferon alfa-2b in patients with 
      unresectable melanoma.
PG  - 85
LID - 10.1186/s40425-016-0194-1 [doi]
LID - 85
AB  - BACKGROUND: Ipilimumab and peginterferon alfa-2b are established systemic 
      treatment options for melanoma that have distinct mechanisms of action. Given the 
      need for improved therapies for advanced melanoma, we conducted an open-label, 
      single institution, phase Ib study to assess the safety and tolerability of using 
      these two agents in combination. METHODS: Study treatment consisted of ipilimumab 
      given every 3 weeks, for a total of four infusions, concurrent with peginterferon 
      alfa-2b administered subcutaneous weekly for a total of 12 weeks. This was 
      followed by maintenance therapy with peginterferon alfa-2b administered 
      subcutaneously weekly for up to 144 additional weeks. The study was designed as a 
      two-stage dose escalation scheme with continuous dose-limiting toxicity 
      monitoring during the induction phase. RESULTS: Thirty one patients received at 
      least 1 dose of study treatment and 30 were assessable for efficacy endpoints. We 
      found that ipilimumab at 3 mg/kg dosing with peginterfeon alfa-2b at 2 mug/kg/week 
      was the maximum tolerated dose of this combination. The incidence of grade 3 
      drug-related adverse events (AEs) was 45.2%. There were no grade 4/5 AEs. The 
      overall response rate was 40% by immune-related response criteria. Median 
      progression-free survival was 5.9 months. The median overall survival was not 
      reached with at a median follow-up of 35.8 months. CONCLUSIONS: We report that 
      the combination of ipilimumab at 3 mg/kg dosing combined with peginterfeon 
      alfa-2b at 2 mug/kg/week demonstrated an acceptable toxicity profile and a 
      promising efficacy signal. Further study of this combination is warranted. TRIAL 
      REGISTRATION: ClinicalTrials.gov identifier: NCT01496807, Registered December 
      19th, 2011.
FAU - Brohl, Andrew S
AU  - Brohl AS
AD  - Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
FAU - Khushalani, Nikhil I
AU  - Khushalani NI
AD  - Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
FAU - Eroglu, Zeynep
AU  - Eroglu Z
AD  - Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
FAU - Markowitz, Joseph
AU  - Markowitz J
AD  - Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA.
FAU - Thapa, Ram
AU  - Thapa R
AD  - Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and 
      Research Institute, Tampa, FL USA.
FAU - Chen, Y Ann
AU  - Chen YA
AD  - Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and 
      Research Institute, Tampa, FL USA.
FAU - Kudchadkar, Ragini
AU  - Kudchadkar R
AD  - Winship Cancer Institute of Emory University, Atlanta, GA USA.
FAU - Weber, Jeffrey S
AU  - Weber JS
AD  - Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, 12902 Magnolia Drive, Tampa, FL 33612-9416 USA ; New York University 
      Langone Medical Center, New York, NY USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01496807
GR  - P30 CA076292/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20161220
PL  - England
TA  - J Immunother Cancer
JT  - Journal for immunotherapy of cancer
JID - 101620585
PMC - PMC5170897
OTO - NOTNLM
OT  - Clinical trial
OT  - Immunotherapy
OT  - Ipilimumab
OT  - Melanoma
OT  - Peginterferon alfa-2b
EDAT- 2016/12/30 06:00
MHDA- 2016/12/30 06:01
PMCR- 2016/12/20
CRDT- 2016/12/30 06:00
PHST- 2016/09/28 00:00 [received]
PHST- 2016/11/14 00:00 [accepted]
PHST- 2016/12/30 06:00 [entrez]
PHST- 2016/12/30 06:00 [pubmed]
PHST- 2016/12/30 06:01 [medline]
PHST- 2016/12/20 00:00 [pmc-release]
AID - 194 [pii]
AID - 10.1186/s40425-016-0194-1 [doi]
PST - epublish
SO  - J Immunother Cancer. 2016 Dec 20;4:85. doi: 10.1186/s40425-016-0194-1. 
      eCollection 2016.