Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
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.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 103 papers, 6 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
103 citing papers in PubMed, 6 syntheses or guidelines pooled it, 173 citations in OpenAlex.
- Sex, Timing, and Outcomes of Curative-Intent Immunotherapy: A Systematic Review and Meta-Analysis.JAMA network open · 2026Pooled it
- Adjuvant immune checkpoint inhibitors across solid tumors: a meta-analysis of phase II-III randomized trials.Frontiers in oncology · 2026Pooled it
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma, version 3.0.Journal for immunotherapy of cancer · 2023Guideline
- Evaluating relapse-free survival as an endpoint for overall survival in adjuvant immunotherapy trials.Journal of the National Cancer Institute · 2023Pooled it
- Efficacy and safety of immune checkpoint inhibitors and targeted therapies in resected melanoma: a systematic review and network meta-analysis.Frontiers in pharmacology · 2023Pooled it
- Comprehensive Evaluation of Anti-PD-1, Anti-PD-L1, Anti-CTLA-4 and Their Combined Immunotherapy in Clinical Trials: A Systematic Review and Meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Integrative Immune Signature of Complementary Circulating and Tumoral Biomarkers Maximizes the Predictive Power of Adjuvant Immunotherapeutic Benefits in High-risk Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Trial
- Improved prognosis and evidence of enhanced immunogenicity in tumor and circulation of high-risk melanoma patients with unknown primary.Journal for immunotherapy of cancer · 2022Trial
- Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis.Journal for immunotherapy of cancer · 2021Trial
- 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.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Linking early and late endpoints in adjuvant immunotherapy trials: an evaluation of multiple clinical outcomes.The oncologist · 2026Article
- Pre-treatment T-cell Transcriptional Signatures Predict Immunotherapy Outcomes in Melanoma.Research square · 2026Article
- Predicting immune-related thyroiditis using polygenic risk scores in patients with advanced melanoma.Journal for immunotherapy of cancer · 2026Article
- Adjuvant Approaches in Fully Resected Stage III and IV Cutaneous Melanoma: Where Are We Now?Cancers · 2026Review
- Insights into inherited genetic variations and genetic ancestry of patients with high-risk melanoma.Melanoma research · 2026Article
- Immune Checkpoint Inhibitor-Associated Cardiovascular Toxicity: Mechanisms, Clinical Manifestations, and Clinical Impact.Cardiovascular toxicology · 2026Review
- Reconsidering adjuvant and perioperative immune-checkpoint inhibition: de-escalation, expansion and personalization.Nature reviews. Clinical oncology · 2026Review
- Multicellular immune ecotypes within solid tumors predict real-world therapeutic benefits with immune checkpoint inhibitors.Nature communications · 2025Article
- Article
43 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
21 authors at 17 institutions in 2 countries.
Funding
Abstract
purposePhase III adjuvant trials have reported significant benefits in both relapse-free survival (RFS) and overall survival (OS) for high-dose interferon alfa (HDI) and ipilimumab at 10 mg/kg (ipi10). E1609 evaluated the safety and efficacy of ipilimumab at 3 mg/kg (ipi3) and ipi10 versus HDI. PATIENTS AND
methodsE1609 was a phase III trial in patients with resected cutaneous melanoma (American Joint Committee on Cancer 7th edition stage IIIB, IIIC, M1a, or M1b). It had 2 coprimary end points: OS and RFS. A 2-step hierarchic approach first evaluated ipi3 versus HDI followed by ipi10 versus HDI.
resultsBetween May 2011 and August 2014, 1,670 adult patients were centrally randomly assigned (1:1:1) to ipi3 (n = 523), HDI (n = 636), or ipi10 (n = 511). Treatment-related adverse events grade ≥ 3 occurred in 37% of patients receiving ipi3, 79% receiving HDI, and 58% receiving ipi10, with adverse events leading to treatment discontinuation in 35%, 20%, and 54%, respectively. Comparison of ipi3 versus HDI used an intent-to-treat analysis of concurrently randomly assigned patient cases (n = 1,051) and showed significant OS difference in favor of ipi3 (hazard ratio [HR], 0.78; 95.6% repeated CI, 0.61 to 0.99;
conclusionAdjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen. The currently approved adjuvant ipilimumab dose (ipi10) was more toxic and not superior in efficacy to HDI.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.