# Ipilimumab

Source: https://onco.cc/drugs/ipilimumab/  
OnCo record `ipilimumab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ipilimumab was the first checkpoint inhibitor (2011), and proved the immune system could be unleashed against cancer.

## Summary

Ipilimumab is a fully human IgG1 antibody against CTLA-4 that enhances T-cell priming by stopping CTLA-4 from outcompeting CD28 for B7 ligands, and depletes intratumoural regulatory T cells through Fc effector function. It was the first checkpoint inhibitor, approved in 2011 for metastatic melanoma after monotherapy improved overall survival (2010 NEJM), and proved the immune system could be unleashed against cancer. It is now mostly given with nivolumab in melanoma, RCC, MSI-high colorectal cancer, HCC, mesothelioma and NSCLC, at 3 mg/kg in melanoma and 1 mg/kg elsewhere. In CheckMate 067 the combination produced 10-year overall survival of 43 percent versus 37 percent for nivolumab alone and 19 percent for ipilimumab alone. Immune-related adverse events are frequent, with colitis in 25 percent and hepatitis in 15 percent alongside nivolumab, and severe cases end treatment.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Yervoy
- Modality: Monoclonal antibody (anti-CTLA-4)
- Mechanism: Fully human IgG1 anti-CTLA-4; enhances T-cell priming and depletes intratumoural Tregs.
- Approvals: US 2011: Metastatic melanoma; England (NICE) 2025: Untreated unresectable or metastatic MSI-high or dMMR colorectal cancer, with nivolumab; England (NICE) 2021: Untreated metastatic non-small-cell lung cancer, with nivolumab and two cycles of platinum doublet chemotherapy: not recommended
- Dosing: IV infusion; Melanoma monotherapy 3 mg/kg every 3 weeks ×4; with nivolumab 3 mg/kg (melanoma) or 1 mg/kg (RCC, NSCLC, HCC, MSI-H CRC) every 3 or 6 weeks
- Toxicity (grade 3+): Colitis (with nivolumab 1+3) 14.4%; Hepatitis (with nivolumab) 13.4%; Hypothyroidism (with nivolumab) 0.4%; Rash (with nivolumab) 4.8%; Adrenal insufficiency (with nivolumab) 2.6%; Hyperthyroidism (with nivolumab) 0.9%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Ipilimumab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ipilimumab
- NICE TA1065: https://www.nice.org.uk/guidance/ta1065
- NICE TA724: nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer (not recommended): https://www.nice.org.uk/guidance/ta724

## Connected records

- cancers: [Acral melanoma](https://onco.cc/cancers/acral-melanoma/), [Advanced hepatocellular carcinoma (BCLC C)](https://onco.cc/cancers/hcc-advanced/), [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Angiosarcoma](https://onco.cc/cancers/angiosarcoma/), [BRAF V600E-mutant colorectal cancer](https://onco.cc/cancers/braf-v600e-colorectal/), [Brain metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [BRCA or PALB2-mutant pancreatic ductal adenocarcinoma](https://onco.cc/cancers/brca-palb2-pdac/), [Clear cell renal cell carcinoma](https://onco.cc/cancers/clear-cell-rcc/), [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Extrapulmonary neuroendocrine carcinoma](https://onco.cc/cancers/extrapulmonary-nec/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Melanoma](https://onco.cc/cancers/melanoma/), [Merkel cell carcinoma](https://onco.cc/cancers/merkel-cell-carcinoma/), [Mesothelioma](https://onco.cc/cancers/mesothelioma/), [Microsatellite-unstable (MSI-high) gastric cancer](https://onco.cc/cancers/gastric-msi-high/), [Mismatch repair deficient (MSI-high) pancreatic ductal adenocarcinoma](https://onco.cc/cancers/msi-high-pdac/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Mucosal melanoma](https://onco.cc/cancers/mucosal-melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/), [Peritoneal mesothelioma](https://onco.cc/cancers/peritoneal-mesothelioma/), [Pleural mesothelioma](https://onco.cc/cancers/pleural-mesothelioma/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/), [Uveal melanoma](https://onco.cc/cancers/uveal-melanoma/), [Vascular tumours (angiosarcoma, epithelioid haemangioendothelioma, kaposiform haemangioendothelioma)](https://onco.cc/cancers/vascular-tumours/), [Vulvar melanoma](https://onco.cc/cancers/vulvar-melanoma/)
- technologies: [Dietary fibre and the gut microbiome for immunotherapy response](https://onco.cc/technologies/dietary-fibre-microbiome-io/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Immune endocrine damage is usually permanent, and almost nobody is told](https://onco.cc/technologies/rejuv-recovery-endocrine-permanence/), [Probiotics, antibiotics and stewardship around immunotherapy](https://onco.cc/technologies/probiotics-antibiotic-stewardship-io/)
- targets: [CD28](https://onco.cc/targets/cd28/), [CD80 (B7-1)](https://onco.cc/targets/cd80/), [CD86 (B7-2)](https://onco.cc/targets/cd86/), [CTLA-4](https://onco.cc/targets/ctla4/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- trials: [A 2-part Phase 1/2 Open-label Trial on ODM-212](https://onco.cc/trials/nct07563738/), [A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors](https://onco.cc/trials/nct05584670/), [A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult P](https://onco.cc/trials/nct06581406/), [A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer](https://onco.cc/trials/nct03873402/), [A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy](https://onco.cc/trials/nct06362369/), [A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)](https://onco.cc/trials/nct05144854/), [A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unres](https://onco.cc/trials/nct07291076/), [A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal ](https://onco.cc/trials/nct07293351/), [A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Pre](https://onco.cc/trials/nct06946797/), [BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab](https://onco.cc/trials/nct04933903/), [CA184-043](https://onco.cc/trials/ca184-043-ipilimumab/), [CheckMate 067](https://onco.cc/trials/checkmate-067/), [CheckMate 142](https://onco.cc/trials/checkmate-142/), [CheckMate 204](https://onco.cc/trials/checkmate-204/), [CheckMate 214](https://onco.cc/trials/checkmate-214/), [CheckMate 227](https://onco.cc/trials/checkmate-227/), [CheckMate 238](https://onco.cc/trials/checkmate-238/), [CheckMate 358](https://onco.cc/trials/checkmate-358/), [CheckMate 648](https://onco.cc/trials/checkmate-648/), [CheckMate 743](https://onco.cc/trials/checkmate-743/), [CheckMate 8HW](https://onco.cc/trials/checkmate-8hw/), [CheckMate 915](https://onco.cc/trials/checkmate-915/), [CheckMate 9DW](https://onco.cc/trials/checkmate-9dw/), [CheckMate 9LA](https://onco.cc/trials/checkmate-9la/), [Combination Immunotherapy in Rare Cancers Under InvesTigation](https://onco.cc/trials/nct04969887/), [COSMIC-313](https://onco.cc/trials/cosmic-313/), [DART (SWOG S1609): nivolumab plus ipilimumab in rare tumours](https://onco.cc/trials/dart-s1609/), [Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma](https://onco.cc/trials/nct06784648/), [DREAMseq (ECOG-ACRIN EA6134)](https://onco.cc/trials/dreamseq/), [First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07355205/), [IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma](https://onco.cc/trials/nct05987332/), [Immunotherapy in Patients With Early dMMR Rectal Cancer](https://onco.cc/trials/nct05732389/), [KEYNOTE-006](https://onco.cc/trials/keynote-006/), [Lung-MAP (SWOG S1400 and S1900)](https://onco.cc/trials/lung-map/), [Lung-MAP S1400I: nivolumab with or without ipilimumab](https://onco.cc/trials/lung-map-s1400i/), [Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy](https://onco.cc/trials/nct06747845/), [MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma](https://onco.cc/trials/nct06097728/), [NADINA](https://onco.cc/trials/nadina/), [NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer](https://onco.cc/trials/nct06941857/), [NCI9673](https://onco.cc/trials/nci9673/), [Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer](https://onco.cc/trials/nct07403877/), [NICHE-2](https://onco.cc/trials/niche-2/), [Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC](https://onco.cc/trials/nct05310643/), [Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer](https://onco.cc/trials/nct03391869/), [NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial](https://onco.cc/trials/nct06342037/), [Pan Tumor Rollover Study](https://onco.cc/trials/nct03899155/), [Ph I/II Trial of Systemic VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Select Solid Tumors](https://onco.cc/trials/nct03647163/), [Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer](https://onco.cc/trials/nct03907852/), [Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis](https://onco.cc/trials/nct06047379/), [Sintilimab Combined With Ipilimumab (N01) Plus AG as First-line Therapy for uBTC.](https://onco.cc/trials/nct07654530/), [Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer](https://onco.cc/trials/nct05501665/), [Study of LP-184 in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct05933265/), [Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct05533697/), [Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer](https://onco.cc/trials/nct03036098/), [Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)](https://onco.cc/trials/nct03865082/), [Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a](https://onco.cc/trials/nct07227012/), [Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With ](https://onco.cc/trials/nct07227415/), [TAPUR (Targeted Agent and Profiling Utilization Registry)](https://onco.cc/trials/tapur/), [Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Pati](https://onco.cc/trials/nct04929041/), [The Sagittarius Trial](https://onco.cc/trials/nct06490536/), [Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors](https://onco.cc/trials/nct05187338/)
- people: [Alexander Eggermont](https://onco.cc/people/alexander-eggermont/), [Caroline Robert](https://onco.cc/people/caroline-robert/), [Christian Blank](https://onco.cc/people/christian-blank/), [F. Stephen Hodi](https://onco.cc/people/f-stephen-hodi/), [Georgina V. Long](https://onco.cc/people/georgina-long/), [Heinz-Josef Lenz](https://onco.cc/people/heinz-josef-lenz/), [Hussein A. Tawbi](https://onco.cc/people/hussein-tawbi/), [Igor Puzanov](https://onco.cc/people/igor-puzanov/), [Inge Marie Svane](https://onco.cc/people/inge-marie-svane/), [James Larkin](https://onco.cc/people/james-larkin/), [James P. Allison](https://onco.cc/people/james-allison/), [Jedd D. Wolchok](https://onco.cc/people/jedd-wolchok/), [Jeffrey S. Weber](https://onco.cc/people/jeffrey-weber/), [Jennifer A. Wargo](https://onco.cc/people/jennifer-wargo/), [John Haanen](https://onco.cc/people/john-haanen/), [Laurence Albiges](https://onco.cc/people/laurence-albiges/), [Michael A. Postow](https://onco.cc/people/michael-postow/), [Myriam Chalabi](https://onco.cc/people/myriam-chalabi/), [Paolo A. Ascierto](https://onco.cc/people/paolo-ascierto/), [Paul Baas](https://onco.cc/people/paul-baas/), [Robert J. Motzer](https://onco.cc/people/robert-motzer/), [Sharon Belvin](https://onco.cc/people/sharon-belvin/), [Solange Peters](https://onco.cc/people/solange-peters/), [Sumanta K. Pal](https://onco.cc/people/sumanta-pal/), [Thierry André](https://onco.cc/people/thierry-andre/), [Tina Cascone](https://onco.cc/people/tina-cascone/)
- key papers: [ASCO 2021 guideline: how to recognise and manage the immune-related side effects of checkpoint inhibitors](https://onco.cc/key-papers/paper-asco-irae-guideline-jco-2021/), [CheckMate 067 at ten years: nivolumab plus ipilimumab produces long-term survival in half of patients with advanced melanoma](https://onco.cc/key-papers/paper-checkmate-067-10-year-nejm-2025/), [CheckMate 214: nivolumab plus ipilimumab versus sunitinib in advanced renal cell carcinoma](https://onco.cc/key-papers/paper-checkmate-214-nejm-2018/), [CheckMate 238: adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma](https://onco.cc/key-papers/paper-checkmate-238-nejm-2017/), [CheckMate 649: nivolumab plus chemotherapy as first treatment for advanced gastric, gastro-oesophageal junction and oesophageal adenocarcinoma](https://onco.cc/key-papers/paper-checkmate-649-lancet-2021/), [CheckMate 743: first-line nivolumab plus ipilimumab in unresectable pleural mesothelioma](https://onco.cc/key-papers/paper-checkmate-743-lancet-2021/), [CheckMate 8HW: nivolumab plus ipilimumab versus nivolumab alone in MSI-high metastatic colorectal cancer](https://onco.cc/key-papers/paper-checkmate-8hw-lancet-2025/), [Depletion of carcinoma-associated fibroblasts and fibrosis induces immunosuppression and accelerates pancreas cancer with reduced survival](https://onco.cc/key-papers/paper-ozdemir-caf-depletion-accelerates-pancreatic-cancer-cancer-cell-2014/), [DREAMseq (ECOG-ACRIN EA6134): sequencing dabrafenib-trametinib and nivolumab-ipilimumab in BRAF-mutant metastatic melanoma](https://onco.cc/key-papers/paper-dreamseq-jco-2023/), [Hodi 2010: ipilimumab, the first checkpoint inhibitor, extends survival in metastatic melanoma](https://onco.cc/key-papers/paper-hodi-ipilimumab-melanoma-nejm-2010/), [KEYNOTE-006 (Robert 2015): pembrolizumab versus ipilimumab in advanced melanoma](https://onco.cc/key-papers/paper-keynote-006-pembrolizumab-ipilimumab-melanoma-nejm-2015/), [Leach, Krummel and Allison: releasing the CTLA-4 brake makes mice reject tumours](https://onco.cc/key-papers/paper-leach-allison-ctla4-blockade-science-1996/), [NADINA: two doses of ipilimumab plus nivolumab before surgery beat a year of nivolumab after surgery in stage III melanoma](https://onco.cc/key-papers/paper-nadina-nejm-2024/), [NCI9673 part B: randomised phase 2 study of nivolumab with or without ipilimumab in refractory metastatic anal cancer](https://onco.cc/key-papers/paper-nci9673-part-b-nivolumab-ipilimumab-anal-cancer-morris-jco-2026/), [NICHE-2: a month of nivolumab and ipilimumab before surgery clears mismatch-repair-deficient colon cancer in most patients](https://onco.cc/key-papers/paper-niche-2-nejm-2024/), [Nivolumab alone or with ipilimumab in mucosal melanoma: pooled analysis](https://onco.cc/key-papers/paper-dangelo-mucosal-melanoma-pooled-jco-2017/), [Nivolumab plus ipilimumab in microsatellite-instability-high metastatic colorectal cancer (CheckMate 8HW)](https://onco.cc/key-papers/paper-andre-checkmate-8hw-nivolumab-ipilimumab-nejm-2024/), [Phase 2 trial of single agent ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma](https://onco.cc/key-papers/paper-royal-ipilimumab-pancreatic-j-immunother-2010/), [Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma](https://onco.cc/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/)
- pairings: [Histology → first-line choice in mesothelioma](https://onco.cc/pairings/histology-directs-first-line-meso/), [IMDC risk → first-line regimen choice (RCC)](https://onco.cc/pairings/risk-directed-first-line-rcc/), [Immunotherapy first, then BRAF/MEK (BRAF-mutant melanoma)](https://onco.cc/pairings/io-first-then-braf-mek/), [Neoadjuvant checkpoint inhibitor → surgery (or no surgery) in dMMR colorectal cancer](https://onco.cc/pairings/neoadjuvant-io-dmmr/), [Neoadjuvant immunotherapy → response-adapted adjuvant](https://onco.cc/pairings/neoadjuvant-io-response-adapted/)
- terms: [Colorectal cancer drugs in England: what NICE has recommended](https://onco.cc/terms/colorectal-uk-drug-access/), [Immune checkpoint](https://onco.cc/terms/immune-checkpoint/), [Immune surveillance and cancer immunoediting](https://onco.cc/terms/immune-surveillance-immunoediting/), [Immune-mediated colitis and diarrhoea](https://onco.cc/terms/immune-colitis/), [Immune-related endocrinopathies (thyroiditis, hypophysitis)](https://onco.cc/terms/immune-endocrinopathy/), [Immuno-oncology (IO) and checkpoint blockade](https://onco.cc/terms/immuno-oncology/), [Interferon-gamma gene signature (T-cell-inflamed signature)](https://onco.cc/terms/interferon-gamma-signature/), [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/), [Sarcomatoid differentiation (RCC)](https://onco.cc/terms/sarcomatoid-rcc/)
- ideas: [Predict immune side-effects before they happen and pre-empt them](https://onco.cc/ideas/idea-moon-irae-prediction-and-prevention/), [Select microsatellite stable patients for immunotherapy by a measured immune biomarker, not by how many treatments they have already failed](https://onco.cc/ideas/idea-crc-mss-immunotherapy-by-biomarker-not-by-line/), [Treat the draining lymph node before removing it](https://onco.cc/ideas/idea-bio2-lymph-node-immune-priming/)
- pathways: [Colorectal cancer (KEGG map)](https://onco.cc/pathways/colorectal-cancer-signalling/), [Melanoma (KEGG map)](https://onco.cc/pathways/melanoma-signalling/), [Mismatch repair & microsatellite instability](https://onco.cc/pathways/mismatch-repair-msi/), [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/), [Renal cell carcinoma (KEGG map)](https://onco.cc/pathways/renal-cell-carcinoma-signalling/), [The cancer-immunity cycle](https://onco.cc/pathways/cancer-immunity-cycle/)
- roadmaps: [Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity](https://onco.cc/roadmaps/immunotherapy-roadmap/)
- institutions: [Dartmouth Cancer Center](https://onco.cc/institutions/dartmouth-cancer-center/), [Istituto Nazionale Tumori IRCCS Fondazione G. Pascale](https://onco.cc/institutions/pascale-naples/), [West German Cancer Center (WTZ), University Hospital Essen](https://onco.cc/institutions/essen-wtz/)
- biomarkers: [dMMR (mismatch repair deficiency by IHC)](https://onco.cc/biomarkers/dmmr-ihc/), [MSI-high (microsatellite instability by PCR or sequencing)](https://onco.cc/biomarkers/msi-high/), [PD-L1 TC score (tumour-cell score, SP263 and 28-8)](https://onco.cc/biomarkers/pd-l1-tc-score/)
- drugs: [Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes)](https://onco.cc/drugs/tacquell/)

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