407P Pembrolizumab Expanded Access Program (EAP) in Taiwan for patients with progressive advanced melanoma after prior ipilimumab treatment

2016 ◽  
Vol 27 (suppl_9) ◽  
Author(s):  
C-K. Yang ◽  
J-H. Liu ◽  
C-C. Lin ◽  
T-C. Liu ◽  
P-T. Cheng ◽  
...  
2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e21058-e21058
Author(s):  
Elisa A. Rozeman ◽  
Yanina Jansen ◽  
MarnixMarnix Heimen Geukes Foppen ◽  
Max Schreuer ◽  
Sofie Wilgenhof ◽  
...  

2013 ◽  
Vol 36 (3) ◽  
pp. 215-222 ◽  
Author(s):  
Sofie Wilgenhof ◽  
Stephanie Du Four ◽  
Frederik Vandenbroucke ◽  
Hendrik Everaert ◽  
Isabelle Salmon ◽  
...  

2017 ◽  
Vol 19 (6) ◽  
pp. 761-768 ◽  
Author(s):  
M. González-Cao ◽  
◽  
A. Arance ◽  
J. M. Piulats ◽  
I. Marquez-Rodas ◽  
...  

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 9525-9525 ◽  
Author(s):  
Paul B. Chapman ◽  
Mario Sznol ◽  
Christopher Lao ◽  
Rene Gonzalez ◽  
Gregory A. Daniels ◽  
...  

2020 ◽  
Vol 27 (4) ◽  
Author(s):  
D. Hogg ◽  
J. G. Monzon ◽  
S. Ernst ◽  
X. Song ◽  
E. McWhirter ◽  
...  

Background Combination nivolumab and ipilimumab is approved for the first-line treatment of patients with advanced melanoma in several jurisdictions (United States, European Union, and Canada). CheckMate 218 is a North American expanded access program (EAP) of nivolumab plus ipilimumab in patients with advanced melanoma. We report safety and survival outcomes of the Canadian cohort in this EAP.Methods Eligible patients were aged ≥18 years with unresectable stage III or stage IV melanoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no prior anti–PD-1 or anti–CTLA-4 therapy. Patients were treated with nivolumab 1 mg/kg combined with ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase) and then continued with nivolumab 3 mg/kg every 2 weeks (maintenance phase) until progression, unacceptable toxicity, or a maximum of 48 weeks, whichever occurred first. Safety and overall survival (OS) data were collected.Results A total of 194 patients were enrolled; 174 were treated, and 51% continued on nivolumab maintenance. The median follow-up time was 12.9 months. All-grade and grade 3–4 treatment-related adverse events were reported in 98% and 60% of patients, respectively, and led to treatment discontinuation in 40% and 28% of patients, respectively. Two treatment-related deaths were reported. Twelve- and 18-month OS rates were 80% (95% confidence interval [CI]: 73 to 86) and 76% (95% CI: 67 to 82), respectively.Conclusion In this Canadian population, nivolumab plus ipilimumab demonstrated a safety profile and survival outcomes consistent with phase 2 and 3 clinical trial data.Trial registration: NCT02186249


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19027-e19027
Author(s):  
Stephanie Du Four ◽  
Sofie Wilgenhof ◽  
Amelie Clementine Seghers ◽  
Johnny Duerinck ◽  
Bart Neyns

e19027 Background: patients (pts) diagnosed with melanoma brain metastases (MBM) have a poor prognosis with conventional treatment options. Ipilimumab (IPI) is a CTLA-4 blocking monoclonal antibody with established activity in patients (pts) with pretreated advanced melanoma. Methods: observational study on the clinical outcome of melanoma pts with a prior diagnosis of MBM among pts treated with IPI (3 mg/kg q3wks x4, allowing for retreatment after a PFS of >24 wks) in an expanded access program at a single center. Results: among the 50 pts who initiated IPI treatment between April 2010 and May 2011, 16 pts had been diagnosed with MBM. Only 1 pt had a solitary MBM, all other pts had > 3 MBM. Baseline characteristics for pts with- and without MBM: M/F 8/8 vs. 20/14; mAge 44- vs. 50y; BRAF V600-mut/wt 10/6 vs 19/15; stage IV-M1c/-a&b 16/0 vs 31/3; WHO-PS 0-1/2 9/7 vs 30/4; LDH >ULN 10/6 vs 23/11; CRP >ULN 10/6 vs 20/14; ALC<1000/mm³ 3/13 vs 11/23. All pts were pretreated with DTIC; 3 pts with stereotactic (stRT), 7 pts with WBRT, and 2 pts with WBRT followed by a stRT boost; 4 pts had no prior therapy for MBM. 7/16 pts with- vs. 24/34 pts without MBM completed IPI-treatment; 3/16 pts with- vs 8/34 pts without MBM had IPI-retreatment. Adverse events were managed following established guidelines and were generally mild/reversible (<20% pts gr3-, none gr4/5) and similar in pts with- or without MBM at the exception of symptomatic radiation necrosis of the brain (RNB) observed in 3 pts (1x gr2, 2x gr3). Following surgery (1pt), and corticotherapy (3pts) all pts recovered their RNB related symptoms. Best objective tumor response (BOR) by RECIST outside the CNS in pts with- vs without MBM was 1PR vs. 1CR/2PR/4SD; according to the immune-related response criteria: 3PR vs. 1CR/2PR/7SD. After a median follow-up of 18 months, 32 pts have died (11/16 with- vs. 21/34 without MBM). The probability for OS was not significantly different for pts with- or without MBM (HR .76 [95%CI 0.36-1.59]; p: .475 by Log-Rank test). Conclusions: in our single-center experience with IPI for pts with advanced melanoma treated in an EAP, the probability for OS for patients with a prior history of MBM was not significantly different from pts without a prior history of MBM.


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