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 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

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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