SWOG clinical trial number
CTSU/E1609

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon Alpha-2b for Resected High-Risk Melanoma

Closed
Phase
Abbreviated Title
Randomized Ph III of ipilimumab vs hdi in resected high-risk melanoma
Activated
07/15/2011
Participants
CTSU

Research committees

Melanoma

Treatment

Interferon alpha-2b Ipilimumab

Eligibility Criteria Expand/Collapse

SWOG has endorsed this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Please contact the CTSU directly by either phone (1-888-823-5923) or on the CTSU web site (http://ctsu.org/) for more information and registration procedures.

Publication Information Expand/Collapse

2023

Granulomatous and Sarcoid-like Immune Related Adverse Events Following CTLA4 and PD1 Blockade Adjuvant Therapy of Melanoma: A Combined Analysis of ECOG-ACRIN E1609 and SWOG S1404 Phase III Trials and A Literature Review

I Eljilany;A Noor;M Paravathaneni;I Yassine;S Lee;M Othus;J Moon;J Kirkwood;V Sondak;A Ribas;K Grossmann;A Tarhini Cancers (Basel) Apr 29;15(9):2561

PMid: PMID37174027 | PMC number: PMC10177189

2021

Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of hormone replacement and immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis

A Tarhini;N Kang;S Lee;F Hodi;U Rao;G Cohen;O Hamid;L Hutchins;J Sosman;H Kluger;Z Eroglu;H Koon;D Lawrence;K Kendra;D Minor;C Lee;M Albertini;L Flaherty;T Petrella;H Streicher;V Sondak;J Kirwood Journal for Immunotherapy of Cancer May;9(5):e002535. doi: 10.1136/jitc-2021-002535

PMid: PMID33963015 | PMC number: PMC8108687

Granulomatous and sarcoid-like immune related adverse events (irAEs) in melanoma patients following CTLA4 blockade blockade adjuvant therapy: An analysis of 1670 high-risk patients

A Noor;I Nassine;S Lee;M Othus;J Moon;J Kirkwood;V Sondak;A Ribas;K Grossmann;A Tarhini J Clin Oncol 39, 2021 (suppl 15; abstr 9582) (American Society of Clinical Oncology Annual Meeting 2021, poster session)

Granulomatous and sarcoid-like immune related adverse events (irAEs) following CTLA4 and PD1 blockade adjuvant therapy of high-risk melanoma: A combined analysis of ECOG-ACRIN E1609 and SWOG S1404 Phase III Trials

A Noor;I Yassine;S Lee;M Othus;J Moon;J Kirkwood;V Sondak;A Ribas;K Grossmann;A Tarhini Annals of Oncology 32 (suppl_5): S867-S905. 10.1016/annonc/annonc706ESMO Annual Meeting (September 16-21, 2021), accepted, E-poster presentation abst #1069P

Enhanced immunogenicity within the tumor microenvironment and the circulation of high-risk melanoma patients with unknown primary compared to those whose primary melanoma is known

A Tarhini;A Tan;I El Naqa;S Lee;F Hodi;L Butterfield;W LaFramboise;W Storkus;J Conejo-Garcia;P Hwu;H Streicher;V Sondak;J Kirkwood Society for Immunotherapy of Cancer’s (SITC) Annual Meeting (Nov 10-14, 2021, Washington, DC), poster

Females with high-risk melanoma are more likely to benefit from CTLA4 immune checkpoint inhibition with associated evidence of enhanced immune activation within the TME and the circulation

M Saad;A Tan;I El Naqa;S Lee;S Hodi;S Butterfield;W LaFramboise;W Storkus;J Conejo-Garcia;P Hwu;H Streicher;V Sondak;J Kirkwood;A Tarhini Society for Immunotherapy of Cancer’s (SITC) Annual Meeting (Nov 10-14, 2021, Washington, DC), poster

2020

Immune related adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of hormone replacement and immunosuppressants and association with outcome: E1609 study analysis

A Tarhini;S Lee;N Kang;F Hodi;U Rao;G Cohen;L Flaherty;T Patrella;V Sondak;JM Kirkwood ASCO-SITC Clinical Immuno-Oncology Symposium (Feb 6-8, 2020, Orlando, FL), Poster Session (Board #C7)

Patient-reported outcomes among patients with resected high-risk melanoma (AJCC7 1118, IIIC, Mla, Mlb) randomized to low- or high-dose adjuvant lpilimumab (ipi) versus high­dose interferon alfa-2b {HDI): Health-related quality of life {HRQL) analysis of ECOG-ACRIN E1609

A Tarhini;Y Zheng;S Lee;F Hodi;U Rao;G Cohen;V Sondak;J Kirkwood;L Wagner J Clin Oncol 38: 2020 (suppl; abstr e22078); American Society of Clinical Oncology Annual Meeting (5/29-6/2/20, Chicago, IL), publication only

Unknown primary tumor high-risk melanoma as a unique patient population with distinct prognosis in the adjuvant setting: An ECOG-ACRIN E1609 study analysis

A Tarhini;S Lee;S Hodi;G Cohen;U Rao;V Sondak;J Kirkwood J Clin Oncol 38: 2020 (suppl; abstr e22090); American Society of Clinical Oncology Annual Meeting (5/29-6/2/20, Chicago, IL), publication only

Female sex is a potential independent predictor of adjuvant immunotherapeutic benefit from CTLA4 immune checkpoint inhibition

A Tarhini;S Lee;S Hodi;U Rao;G Cohen;O Hamid;L Hutchins;J Sosman;H Kluger;Z Eroglu;H Koon;D Lawrence;K Kendra;D Minor;C Lee;M Albertini;L Flaherty;T Petrella;H Streicher;V Sondak;J Kirkwood Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 10-15, 2020, virtual), poster

Phase III Study of Adjuvant Ipilimumab (3 or 10 mg/kg) Versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma: North American Intergroup E1609

A Tarhini;S Lee;FS Hodi;U Rao;G Cohen;O Hamid;L Hutchins;J Sosman;H Kluger;Z Eroglu;H Kooon;D Lawrence;K Kendra;D Minor;C Lee;M Albertini;L Flaherty;T Petrella;H Streicher;V Sondak;J Kirkwood Journal of Clinical Oncology Feb 20;38(6):567-575

PMid: PMID31880964 | PMC number: PMC7030886

2019

United States Intergroup E1609 - A Phase III Randomized Study of Adjuvant Ipilimumab (3 or 10 mg/kg) versus High-Dose Interferon-a2b for Resected High-Risk Melanoma

A Tarhini;S Lee;F Hodi;U Rao;GI Cohen;O Hamid;L Hutchins;J Sosman;H Kluger;V Sondak;H Koon;DP Lawrence;K Kendra;DR Minor;C Lee;M Albertini;L Flaherty;T Petrella;JM Kirkwood J Clin Oncol 37(suppl; abstr 9504); American Society of Clinical Oncology (5/31-6/4/19, Chicago IL), oral

2017

A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon-a2b for resected high-risk melanoma (U.S. Intergroup E1609): preliminary safety and efficacy of the ipilimumab arms

A Tarhini;SJ Lee;FS Hodi;UNM Rao;GI Cohen;O Hamid;L Hutchins;JA Sosman;HM Kluger;VK Sondak;HB Koon;DP Lawrence;K Kendra;DR Minor;CB Lee;MR Albertini;LE Flaherty;TM Petrella;JM Kirkwood J Clin Oncol 35, 2017 (suppl; abstr 9500); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), oral presenation

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