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Current Oncology
Volume 27
Issue 4
10.3747/co.27.5985
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Current Oncology is published by MDPI from Volume 28 Issue 1 (2021). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Multimed Inc..
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Article

Canadian Cohort Expanded-Access Program of Nivolumab Plus Ipilimumab in Advanced Melanoma

by
D. Hogg
1,*,
J.G. Monzon
2,
S. Ernst
3,
X. Song
4,
E. McWhirter
5,
K.J. Savage
6,
B. Skinn
7,
F. Romeyer
8 and
M. Smylie
9
1
Princess Margaret Cancer Centre, Toronto, ON, Canada
2
Tom Baker Cancer Centre, Calgary, AB, Canada
3
Children’s Hospital, London Health Sciences Centre, London, ON, Canada
4
The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada
5
Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada
6
Department of Medical Oncology, BC Cancer, Vancouver, BC, Canada
7
Bristol Myers Squibb, Princeton, NJ, USA
8
Bristol Myers Squibb, Saint-Laurent, QC, Canada
9
Cross Cancer Institute, Edmonton, AB, Canada
*
Author to whom correspondence should be addressed.
Curr. Oncol. 2020, 27(4), 204-214; https://doi.org/10.3747/co.27.5985
Submission received: 6 May 2020 / Revised: 3 June 2020 / Accepted: 6 July 2020 / Published: 1 August 2020

Abstract

Background: The combination of nivolumab and ipilimumab is approved in several jurisdictions (United States, European Union, Canada) for the first-line treatment of patients with advanced melanoma. CheckMate 218 is a North American expanded-access program (EAP) of nivolumab plus ipilimumab in patients with advanced melanoma. Here, we report safety and survival outcomes for the Canadian cohort in the eap. Methods: Eligible patients were those 18 years of age or older with unresectable stage III or 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 and ipilimumab 3 mg/kg every 3 weeks for 4 cycles (induction phase); they 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: Of 194 patients enrolled, 174 were treated, and 51% continued on nivolumab maintenance. Median follow-up was 12.9 months. All-grade and grades 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. Two treatment-related deaths were reported. The 12- and 18-month OS rates were 80% [95% confidence interval (CI): 73% to 86%] and 76% (95% CI: 67% to 82%) respectively. Conclusions: In this Canadian population, nivolumab plus ipilimumab demonstrated a safety profile and survival outcomes consistent with phase II and III clinical trial data.
Keywords: expanded-access programs; immune checkpoint inhibitors; ipilimumab; nivolumab; melanoma expanded-access programs; immune checkpoint inhibitors; ipilimumab; nivolumab; melanoma

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MDPI and ACS Style

Hogg, D.; Monzon, J.G.; Ernst, S.; Song, X.; McWhirter, E.; Savage, K.J.; Skinn, B.; Romeyer, F.; Smylie, M. Canadian Cohort Expanded-Access Program of Nivolumab Plus Ipilimumab in Advanced Melanoma. Curr. Oncol. 2020, 27, 204-214. https://doi.org/10.3747/co.27.5985

AMA Style

Hogg D, Monzon JG, Ernst S, Song X, McWhirter E, Savage KJ, Skinn B, Romeyer F, Smylie M. Canadian Cohort Expanded-Access Program of Nivolumab Plus Ipilimumab in Advanced Melanoma. Current Oncology. 2020; 27(4):204-214. https://doi.org/10.3747/co.27.5985

Chicago/Turabian Style

Hogg, D., J.G. Monzon, S. Ernst, X. Song, E. McWhirter, K.J. Savage, B. Skinn, F. Romeyer, and M. Smylie. 2020. "Canadian Cohort Expanded-Access Program of Nivolumab Plus Ipilimumab in Advanced Melanoma" Current Oncology 27, no. 4: 204-214. https://doi.org/10.3747/co.27.5985

APA Style

Hogg, D., Monzon, J. G., Ernst, S., Song, X., McWhirter, E., Savage, K. J., Skinn, B., Romeyer, F., & Smylie, M. (2020). Canadian Cohort Expanded-Access Program of Nivolumab Plus Ipilimumab in Advanced Melanoma. Current Oncology, 27(4), 204-214. https://doi.org/10.3747/co.27.5985

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