An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma

Combination immunotherapy with sequential administration may enhance metastatic melanoma (MM) patients with long-term disease control. High Dose Aldesleukin/Recombinant Interleukin-2 (HD rIL-2) and ipilimumab (IPI) offer complementary mechanisms against MM. This phase IV study assessed the sequenced...

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Autores principales:	Merve Hasanov, Denái R. Milton, William H. Sharfman, Bret Taback, Lee D. Cranmer, Gregory A Daniels, Lawrence Flaherty, Sigrun Hallmeyer, Mohammed Milhem, Lynn Feun, Ralph Hauke, Gary Doolittle, Nancy Gregory, Sapna Patel
Formato:	article
Lenguaje:	EN
Publicado:	Taylor & Francis Group 2021
Materias:	metastatic melanoma ipilimumab high dose interleukin-2 clinical trial Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/8301b9196dbd4b3ab906e344ff9c4301
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spelling	oai:doaj.org-article:8301b9196dbd4b3ab906e344ff9c43012021-11-04T15:00:45ZAn Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma2162-402X10.1080/2162402X.2021.1984059https://doaj.org/article/8301b9196dbd4b3ab906e344ff9c43012021-01-01T00:00:00Zhttp://dx.doi.org/10.1080/2162402X.2021.1984059https://doaj.org/toc/2162-402XCombination immunotherapy with sequential administration may enhance metastatic melanoma (MM) patients with long-term disease control. High Dose Aldesleukin/Recombinant Interleukin-2 (HD rIL-2) and ipilimumab (IPI) offer complementary mechanisms against MM. This phase IV study assessed the sequenced use of HD rIL-2 and IPI in MM patients. Eligible Stage IV MM patients were randomized to treatment with either two courses of HD rIL-2(600,000 IU/kg) followed by four doses of IPI 3 mg/kg or vice-versa. The primary objective was to compare one-year overall survival (OS) with historical control (46%, Hodi et al., NEJM 2010). Secondary objectives were 1-year progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs) profile. Evaluable Population (EP) included patients who received at least 50% of planned treatment with each drug. Thirteen and 16 patients were randomized to receive HD rIL-2 first, and IPI first, respectively. One-year OS rate was 75% for intention to treat population. Eighteen patients were included in EP, 8 in HD rIL-2, 10 in IPI first arm. In EP, 1-year OS, PFS and ORR rates were 87%, 68%, and 50%, respectively. The frequency of AEs was similar in both arms with 13 patients experiencing Grade 3 or higher AEs, 3 resulting in the end of study participation. There was one HD rIL-2-related death, from cerebral hemorrhage due to thrombocytopenia. In this study with small sample size, HD rIL-2 and IPI were safe to administer sequentially in MM patients and showed more than additive effects. 1-year OS was superior to that of IPI alone from historical studies.Merve HasanovDenái R. MiltonWilliam H. SharfmanBret TabackLee D. CranmerGregory A DanielsLawrence FlahertySigrun HallmeyerMohammed MilhemLynn FeunRalph HaukeGary DoolittleNancy GregorySapna PatelTaylor & Francis Grouparticlemetastatic melanomaipilimumabhigh dose interleukin-2clinical trialImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENOncoImmunology, Vol 10, Iss 1 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	metastatic melanoma ipilimumab high dose interleukin-2 clinical trial Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	metastatic melanoma ipilimumab high dose interleukin-2 clinical trial Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Merve Hasanov Denái R. Milton William H. Sharfman Bret Taback Lee D. Cranmer Gregory A Daniels Lawrence Flaherty Sigrun Hallmeyer Mohammed Milhem Lynn Feun Ralph Hauke Gary Doolittle Nancy Gregory Sapna Patel An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
description	Combination immunotherapy with sequential administration may enhance metastatic melanoma (MM) patients with long-term disease control. High Dose Aldesleukin/Recombinant Interleukin-2 (HD rIL-2) and ipilimumab (IPI) offer complementary mechanisms against MM. This phase IV study assessed the sequenced use of HD rIL-2 and IPI in MM patients. Eligible Stage IV MM patients were randomized to treatment with either two courses of HD rIL-2(600,000 IU/kg) followed by four doses of IPI 3 mg/kg or vice-versa. The primary objective was to compare one-year overall survival (OS) with historical control (46%, Hodi et al., NEJM 2010). Secondary objectives were 1-year progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs) profile. Evaluable Population (EP) included patients who received at least 50% of planned treatment with each drug. Thirteen and 16 patients were randomized to receive HD rIL-2 first, and IPI first, respectively. One-year OS rate was 75% for intention to treat population. Eighteen patients were included in EP, 8 in HD rIL-2, 10 in IPI first arm. In EP, 1-year OS, PFS and ORR rates were 87%, 68%, and 50%, respectively. The frequency of AEs was similar in both arms with 13 patients experiencing Grade 3 or higher AEs, 3 resulting in the end of study participation. There was one HD rIL-2-related death, from cerebral hemorrhage due to thrombocytopenia. In this study with small sample size, HD rIL-2 and IPI were safe to administer sequentially in MM patients and showed more than additive effects. 1-year OS was superior to that of IPI alone from historical studies.
format	article
author	Merve Hasanov Denái R. Milton William H. Sharfman Bret Taback Lee D. Cranmer Gregory A Daniels Lawrence Flaherty Sigrun Hallmeyer Mohammed Milhem Lynn Feun Ralph Hauke Gary Doolittle Nancy Gregory Sapna Patel
author_facet	Merve Hasanov Denái R. Milton William H. Sharfman Bret Taback Lee D. Cranmer Gregory A Daniels Lawrence Flaherty Sigrun Hallmeyer Mohammed Milhem Lynn Feun Ralph Hauke Gary Doolittle Nancy Gregory Sapna Patel
author_sort	Merve Hasanov
title	An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
title_short	An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
title_full	An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
title_fullStr	An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
title_full_unstemmed	An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
title_sort	open–label, randomized, multi–center study comparing the sequence of high dose aldesleukin (interleukin–2) and ipilimumab (yervoy) in patients with metastatic melanoma
publisher	Taylor & Francis Group
publishDate	2021
url	https://doaj.org/article/8301b9196dbd4b3ab906e344ff9c4301
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An Open–Label, Randomized, Multi–Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin–2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma

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