Abstract LB-055: Overall survival and safety experience from an expanded access program (EAP) of nivolumab (NIVO) for patients with advanced melanoma (MEL) who progressed after prior ipilimumab (IPI) treatment

2017 ◽  
Author(s):  
Milton Barros e Silva ◽  
Rafael Schmerling ◽  
Andreia Cristina de Melo ◽  
Sergio Azevedo ◽  
Bernardo Garicochea ◽  
...  
Keyword(s):  
Overall Survival ◽  
Advanced Melanoma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

IPILIMUMAB IN PATIENTS WITH DISSEMINATED MELANOMA: THE N.N. PETROV NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY EXPANDED ACCESS PROGRAM EXPERIENCE

2018 ◽  
Vol 64 (3) ◽  
pp. 388-393
Author(s):  
Yekaterina Anokhina ◽  
V. Rubinchik ◽  
Yekaterina Yaremenko ◽  
Gulfiya Teletaeva ◽  
Dilorom Latipova ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Medical Research ◽  
Research Center ◽  
Expanded Access ◽  
Risk Of Death ◽  
National Medical ◽  
Expanded Access Program ◽  
Access Program

Ipilimumab (IPI) provides a ten-year overall survival in almost 20 % of selected patients participated in several phase II-III trials. However, the expanded access program (EAP) looks more like routine practice than like clinical trials& This is why the results of such application could be different. Here we present the long-term follow-up data of single center EAP. Ninety-six patients with disseminated melanoma progressing after at least one lines of drug therapy were included at the N.N. Petrov National Medical Research Center of Oncology. Sixty-seven (70 %) patients had stage IV M1c, 35 patients (36 %) had elevated LDH before initiating IPI therapy. All patients received IPI 3 mg / kg IV every 3 weeks for a maximum of 4 cycles. Totally, 320 cycles (mean - 3.3 per patient) were conducted. Grade 3-4 immuno-mediated adverse events (imAE) observed in 18 (19 %) patients. Three patients died of adverse events, possibly associated with ongoing therapy. The median time to progression was 3 (95 % CI, 2.4 to 3.5) mo., the median overall survival was 13 (95 % CI, 8.3 to17.6) mo. Previous immunotherapy with dendritic cell vaccines decreased the risk of death by 48 % (Log-rank p = 0.049). The wild type BRAF status increased three-year overall survival from 29 to 68 % (p = 0.042). Our data confirms long-term safety and efficacy of IPI in patients with pretreated disseminated melanoma in the close to real practice setting.

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

2016 ◽  
Vol 27 ◽  
pp. ix127
Author(s):  
C.-K. Yang ◽  
J.-H. Liu ◽  
C.-C. Lin ◽  
T.-C. Liu ◽  
P.-T. Cheng ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

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 ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

scholarly journals Analysis of overall survival by number of radium-223 injections received in an international expanded access program (iEAP)

2016 ◽  
Vol 27 ◽  
pp. iv35 ◽  
Author(s):  
G. Paganelli ◽  
G. Procopio ◽  
M. Cabria ◽  
E. Cortesi ◽  
M. Tucci ◽  
...  
Keyword(s):  
Overall Survival ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Radium 223 ◽  
Access Program

Analysis of overall survival by number of radium-223 injections received in an international expanded access program (iEAP).

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 5082-5082 ◽  
Author(s):  
Fred Saad ◽  
Daniel Keizman ◽  
Joe M. O'Sullivan ◽  
Joan Carles ◽  
Manfred Wirth ◽  
...  
Keyword(s):  
Overall Survival ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Radium 223 ◽  
Access Program

Correlation between baseline characteristics and clinical outcome of patients with pretreated advanced melanoma who received pembrolizumab (PEMBRO) in an expanded access program (EAP).

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e21058-e21058
Author(s):  
Elisa A. Rozeman ◽  
Yanina Jansen ◽  
MarnixMarnix Heimen Geukes Foppen ◽  
Max Schreuer ◽  
Sofie Wilgenhof ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Advanced Melanoma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Baseline Characteristics ◽  
Access Program

Single-Center Experience With Ipilimumab in an Expanded Access Program for Patients With Pretreated Advanced Melanoma

2013 ◽  
Vol 36 (3) ◽  
pp. 215-222 ◽  
Author(s):  
Sofie Wilgenhof ◽  
Stephanie Du Four ◽  
Frederik Vandenbroucke ◽  
Hendrik Everaert ◽  
Isabelle Salmon ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Single Center ◽  
Expanded Access ◽  
Single Center Experience ◽  
Expanded Access Program ◽  
Access Program

scholarly journals Safety and efficacy of combination nivolumab plus ipilimumab in patients with advanced melanoma: results from a North American expanded access program (CheckMate 218)

2020 ◽  
Vol 31 (1) ◽  
pp. 67-75
Author(s):  
F. Stephen Hodi ◽  
Paul B. Chapman ◽  
Mario Sznol ◽  
Christopher D. Lao ◽  
Rene Gonzalez ◽  
...  
Keyword(s):  
North American ◽  
Advanced Melanoma ◽  
Safety And Efficacy ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program

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

Safety data from an expanded access program (EAP) of nivolumab (NIVO) in combination with ipilimumab (IPI) in patients with advanced melanoma (MEL).

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 9525-9525 ◽  
Author(s):  
Paul B. Chapman ◽  
Mario Sznol ◽  
Christopher Lao ◽  
Rene Gonzalez ◽  
Gregory A. Daniels ◽  
...  
Keyword(s):  
Safety Data ◽  
Advanced Melanoma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program
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