Trial reportJournal for immunotherapy of cancer2020
Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.
Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01515189 (A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma), which is not on this map. Cited by 33 papers.
What it found
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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.
A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma
Who cites it
33 citing papers in PubMed.
- Pretreatment and on-treatment ctDNA and tissue biomarkers predict recurrence in patients with stage IIIB-D/IV melanoma treated with adjuvant immunotherapy: CheckMate 915.Journal for immunotherapy of cancer · 2025Trial
- Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- The tumor microenvironment in triple negative breast cancer and a strategy to improve responses to immunotherapy using cryoablation and immunostimulants.Cancer biology & therapy · 2026Review
- Tailored FcγR blockade enhances immune checkpoint therapy and overcomes resistance.Journal of experimental & clinical cancer research : CR · 2026Article
- Advances in Cancer Immunotherapy for Solid Tumors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- New Standards in the Treatment of Advanced Metastatic Melanoma: Immunotherapy and BRAF-Targeted Therapies as Emerging Paradigms.Current pharmaceutical design · 2026Review
- Advanced nanotechnology in enhancing immune checkpoint inhibitors (ICIs) for head and neck cancer therapy.Cell communication and signaling : CCS · 2025Review
- Checkpoint Inhibitors and Beyond: A Systematic Review of Immunotherapy in Cutaneous Malignancies.Cureus · 2025Review
- Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma in Older Patients: An Overview of Published Data.Cancers · 2025Review
- Management of infliximab refractory immune checkpoint inhibitor gastrointestinal toxicity: a multicenter case series.Journal for immunotherapy of cancer · 2024Article
- Refining PD-1/PD-L1 assessment for biomarker-guided immunotherapy: A review.Biomolecules & biomedicine · 2024Review
- Near-infrared duocarmycin photorelease from a Treg-targeted antibody-drug conjugate improves efficacy of PD-1 blockade in syngeneic murine tumor models.Oncoimmunology · 2024Article
- A comprehensive review of immune checkpoint inhibitor-related diabetes mellitus: incidence, clinical features, management, and prognosis.Frontiers in immunology · 2024Review
- Recent advances in immunotherapy and its combination therapies for advanced melanoma: a review.Frontiers in oncology · 2024Review
- Current knowledge about immunotherapy resistance for melanoma and potential predictive and prognostic biomarkers.Cancer drug resistance (Alhambra, Calif.) · 2024Review
- Interleukin 17 signaling supports clinical benefit of dual CTLA-4 and PD-1 checkpoint inhibition in melanoma.Nature cancer · 2023Article
- Immune checkpoint therapy for solid tumours: clinical dilemmas and future trends.Signal transduction and targeted therapy · 2023Review
- Review
- Retreatment of Patients With Metastatic Cutaneous Melanoma Who Relapse After Elective Checkpoint Inhibitor Discontinuation After a Complete Remission.The oncologist · 2023Article
Corrections and comments
- Erratum issuedCorrection:2020
Authors and funding
30 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.
methodsThis randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.
resultsAt a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant
conclusionsThis 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies. TRIAL REGISTRATION NUMBER: NCT01515189.
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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.