Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Open accessAbstract
BACKGROUND: An improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab--which blocks cytotoxic T-lymphocyte-associated antigen 4 to potentiate an antitumor T-cell response--administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma. METHODS: A total of 676 HLA-A*0201-positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could receive reinduction therapy. The primary end point was overall survival. RESULTS: The median overall survival was 10.0 months among patients receiving ipilimumab plus gp100, as compared with 6.4 months among patients receiving gp100 alone (hazard ratio for death, 0.68; P<0.001). The median overall survival with ipilimumab alone was 10.1 months (hazard ratio for death in the comparison with gp100 alone, 0.66; P=0.003). No difference in overall survival was detected between the ipilimumab groups (hazard ratio with ipilimumab plus gp100, 1.04; P=0.76). Grade 3 or 4 immune-related adverse events occurred in 10 to 15% of patients treated with ipilimumab and in 3% treated with gp100 alone. There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events. CONCLUSIONS: Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma. Adverse events can be severe, long-lasting, or both, but most are reversible with appropriate treatment. (Funded by Medarex and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00094653.)
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In 2011, ipilimumab, an anti-CTLA-4 mAb, gained FDA approval based on promising results from a clinical trial in melanoma patients.
“In 2011, based on promising results from a clinical trial in melanoma patients, the first ICI therapy ipilimumab, an anti-CTLA-4 mAb, has gained FDA approval [98].”
From Advances in platinum-based cancer therapy: overcoming platinum resistance through rational combinatorial strategies (2025) · cites this paper as [98]
The paper describes ipilimumab as a monoclonal antibody that blocks CTLA-4, and its Discussion reports improved overall survival in a phase 3 trial involving previously treated patients with metastatic melanoma. It does not establish that ipilimumab was the first immune-checkpoint therapy or that the FDA approved it in 2011 on the basis of this trial; searches for FDA and regulatory approval found no supporting passage. (LLM, conf=0.88)
Experimental — accuracy not yet measuredClinical trials of ICPis excluded patients with pre-existing active autoimmune diseases because of concerns of high susceptibility to severe irAEs.
“Clinical trials of ICPis excluded patients with pre-existing active autoimmune diseases because of concerns of a high susceptibility to severe irAEs [49,50].”
From Graves’ Disease during Immune Checkpoint Inhibitor Therapy (A Case Series and Literature Review) (2021) · cites this paper as [49]
The Methods (Patients; page not provided) list autoimmune disease as an exclusion criterion for this ipilimumab trial. The Results (Adverse Events; page not provided) report severe immune-related adverse events, but the paper does not state that heightened susceptibility to those events in patients with pre-existing autoimmune disease was the reason for exclusion. It also does not establish the claim for checkpoint-inhibitor trials generally. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTreatment with immunotherapy targeting checkpoint inhibitors PD-1 or CTLA-4 significantly increases survival in patients with metastatic melanoma over other standards of care.
“Treatment with immunotherapy targeting checkpoint inhibitors PD-1 or CTLA-4 significantly increases survival in patients with metastatic melanoma over other standards of care [1, 2]”
From Relating the gut metagenome and metatranscriptome to immunotherapy responses in melanoma patients (2019) · cites this paper as [2]
The Abstract Conclusions and Discussion report improved overall survival with the CTLA-4 blocker ipilimumab in previously treated patients with metastatic melanoma. This study did not test PD-1 blockade, and its comparator was the gp100 vaccine, not other standards of care generally. (LLM, conf=0.88)
Experimental — accuracy not yet measuredImmune checkpoint inhibitors greatly enhance clinical outcomes across multiple cancer types.
“While immune checkpoint inhibitors (ICIs) have greatly enhanced clinical outcomes across multiple cancer types,1, 2, 3”
From irAE-GPT: leveraging large language models to identify immune-related adverse events in electronic health records and clinical trial datasets (2026) · cites this paper as [1]
The Discussion (page not supplied) reports that ipilimumab, a checkpoint inhibitor, improved overall survival in previously treated patients with metastatic melanoma. This supports improved outcomes for one inhibitor in one cancer type, but not the claim that inhibitors have enhanced outcomes across multiple cancer types. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAntibodies against CTLA-4 (ipilimumab) or PD1 (nivolumab) induce quick and intense tumor regression in melanoma and NSCLC patients and are under clinical investigation in other solid tumors, including colorectal cancer.
“Antibodies against CTLA-4 (ipilimumab) or PD1 (nivolumab) have been shown to induce quick and intense tumor regression in melanoma and NSCLC patients and are currently under clinical investigation in other solid tumors, including CRC [132, 133]”
From Primary and acquired resistance to EGFR-targeted therapies in colorectal cancer: impact on future treatment strategies (2014) · cites this paper as [132]
There is limited data regarding the safety of ICIs in children.
“Even though ICIs have shown promising results in adults, there is limited data regarding their safety in children [145].”
From Immune Checkpoint Inhibitors in Cancer Therapy (2022) · cites this paper as [145]
Ipilimumab was the first immune checkpoint therapy approved by the FDA, in 2011 for metastatic melanoma, based on phase III trials showing improved overall survival compared with vaccine or chemotherapy.
“Ipilimumab (anti-CTLA4) was the first ICT to gain FDA approval in 2011 for the treatment of metastatic melanoma, on the basis of phase III trials demonstrating improvements in overall survival compared with vaccine or chemotherapy (37,38).”
From The Next Decade of Immune Checkpoint Therapy (2021) · cites this paper as [37]
Ipilimumab was associated with long-term survival in advanced melanoma, with 1-year and 2-year survival rates of 45.6% and 23.5%.
“Ipilimumab was associated with long-term survival effects (1-year and 2-year survival rate of 45.6% and 23.5%, respectively).”
From Hallmarks of response, resistance, and toxicity to immune checkpoint blockade (2021) · cites this paper as Hodi et al., 2010
Ipilimumab treatment was associated with immune-related adverse events in 60% of patients.
“Treatment with Ipilimumab was associated with immune-related adverse events (irAEs) in a surprisingly high 60% of patients (Hodi et al., 2010);”
From Hallmarks of response, resistance, and toxicity to immune checkpoint blockade (2021) · cites this paper as Hodi et al., 2010
In that trial, 20% of patients whose tumors were completely cleared maintained response for the study duration, with median follow-up about 30 months.
“Critically, analogous to what was observed in preclinical studies, the 20% of patients whose tumors were completely cleared maintained their response for the duration of the study, with a median follow-up time of approximately 30 months.”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [32]
The combination of ipilimumab and nivolumab has enhanced response rates in melanoma, lung cancer, renal cell carcinoma, and mismatch repair deficient colon cancer compared with single agent therapy, at the cost of increased toxicities.
“The combination of ipilimumab and nivolumab has demonstrated enhanced response rates in melanoma, lung cancer, renal cell carcinoma, and mismatch repair deficient colon cancer compared with single agent therapy, although at a cost of increased toxicities (see next section).9–11”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [10]
Patients with preexisting autoimmune disorders (ADs) or those receiving systemic immunosuppression for organ transplantation have been universally excluded from clinical trials.
“In order to limit the risk of severe immune-related adverse events (irAEs) or exacerbation of underlying autoimmune or inflammatory disease, patients with preexisting autoimmune disorders (ADs) or those receiving systemic immunosuppression for organ transplantation have been universally excluded from clinical trials.3,4”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [3]
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- Authors
- Hodi, F. S., O'Day, S. J., McDermott, D. F., Weber, R. W., Sosman, J. A., Haanen, J. B., Gonzalez, R., Robert, C., Schadendorf, D., Hassel, J. C., Akerley, W., van den Eertwegh, A. J. M., Lutzky, J., Lorigan, P., Vaubel, J. M., Linette, G. P., Hogg, D., Ottensmeier, C. H., Lebbé, C., Peschel, C., Quirt, I., Clark, J. I., Wolchok, J. D., Weber, J. S., Tian, J., Yellin, M. J., Nichol, G. M., Hoos, A., & Urba, W. J.
- Affiliations
- Dana-Farber Cancer Institute (US)
- Angeles Clinic and Research Institute (US)
- Beth Israel Deaconess Medical Center (US)
- St. Mary's Medical Center (US)
- Vanderbilt University Medical Center (US)
- The Netherlands Cancer Institute (NL)
- University of Colorado Cancer Center (US)
- Institut Gustave Roussy (FR)
- Essen University Hospital (DE)
- University of Mannheim (DE)
- Huntsman Cancer Institute (US)
- Mount Sinai Medical Center (US)
- The Christie Hospital (GB)
- Washington University in St. Louis (US)
- Princess Margaret Cancer Centre (CA)
- University Hospital Southampton NHS Foundation Trust (GB)
- Technical University of Munich (DE)
- Loyola University Medical Center (US)
- Memorial Sloan Kettering Cancer Center (US)
- Moffitt Cancer Center (US)
- Bristol-Myers Squibb (United States) (US)
- ORCID
- Hodi, F. Stephen
- O'Day, Steven J.
- McDermott, David F.
- Sosman, Jeffrey A.
- Haanen, John B.
- Gonzalez, Rene
- Robert, Caroline
- Schadendorf, Dirk
- Hassel, Jessica C.
- Akerley, Wallace
- Lutzky, Jose
- Lorigan, Paul
- Linette, Gerald P.
- Hogg, David
- Ottensmeier, Christian H.
- Peschel, Christian
- Clark, Joseph I.
- Wolchok, Jedd D.
- Weber, Jeffrey S.
- Yellin, Michael J.
- Hoos, Axel
- Urba, Walter J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-08-19
- Volume
- 363
- Issue
- 8
- Pages
- 711-723
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3549297
- OpenAlex
- W2097995306
- Semantic Scholar
- 51d02526aa36effc4d0eedb5649b37a0fbfc57eb
- Cited by
- 15,155
- References
- 37
- Citations by year
- 2026: 414 · 2025: 584 · 2024: 743 · 2023: 876 · 2022: 880 · 2021: 1154 · 2020: 1165 · 2019: 1106 · 2018: 1215 · 2017: 1290 · 2016: 1262 · 2015: 1265 · 2014: 1017 · 2013: 898 · 2012: 692
- FWCI
- 341.03
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- PubMed Central (acceptedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- ePrints Soton (University of Southampton) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Syracuse University
- Moffitt Cancer Center
- National Cancer Institute (K24CA097588)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- ipilimumab, metastatic melanoma, CTLA-4 blockade, immune checkpoint inhibitors, overall survival, immune-related adverse events, HLA-A*0201, cancer immunotherapy, reinduction therapy, T cell response, immune-related pneumonitis, immune-related colitis
- MeSH terms
- Ipilimumab, Antibodies, Monoclonal, Combined Modality Therapy, Double-Blind Method, Female, Humans, Male, Melanoma, Middle Aged, Skin Neoplasms, Antigens, CD, Treatment Outcome, Cancer Vaccines, Kaplan-Meier Estimate, CTLA-4 Antigen
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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