YERVOY (ipilimumab)
YERVOY is indicated for the treatment of Unresectable or metastatic melanoma; Adjuvant treatment of cutaneous melanoma with regional lymph node involvement following complete resection; Intermediate or poor risk advanced renal cell carcinoma; Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer; Unresectable or metastatic hepatocellular carcinoma; Metastatic non-small cell lung cancer expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations; Metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations; Unresectable malignant pleural mesothelioma; Unresectable advanced esophageal cancer.
How YERVOY Works
Ipilimumab is a monoclonal antibody that binds to CTLA-4, a molecule that acts as a negative regulator to suppress T-cell activity. By blocking the interaction between CTLA-4 and its ligands, CD80 and CD86, the drug augments the activation and proliferation of T-effector cells that infiltrate tumors. Additionally, the inhibition of CTLA-4 signaling reduces the suppressive function of T-regulatory cells. These combined actions result in a general increase in T-cell responsiveness and strengthen the body's anti-tumor immune response.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-03-25
- Patent Cliff
- 2025
- Revenue
- $810M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
YERVOY Approval History
What YERVOY Treats
9 indicationsYERVOY is approved for 9 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable or metastatic melanoma
- Adjuvant treatment of cutaneous melanoma with regional lymph node involvement following complete resection
- Intermediate or poor risk advanced renal cell carcinoma
- Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer
- Unresectable or metastatic hepatocellular carcinoma
- Metastatic non-small cell lung cancer expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations
- Metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations
- Unresectable malignant pleural mesothelioma
YERVOY Target & Pathway
ProTarget
An immune checkpoint receptor that downregulates T-cell activation. Unlike PD-1 which works in peripheral tissues, CTLA-4 primarily regulates T-cell activation in lymph nodes. Blocking CTLA-4 enhances T-cell activation and proliferation, boosting anti-tumor immunity.
Pathway Context
CTLA-4 competes with CD28 for binding to CD80/CD86, suppressing T-cell activation
YERVOY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in YERVOY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications YERVOY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to YERVOY
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
572 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05896839 | NCI-2023-04306 NCI-2023-04306, ETCTN10614 | Ph 1, Ph 2 | recruiting | Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer |
| NCT03604991 | NCI-2018-01575 NCI-2018-01575, EA2174 | Ph 2, Ph 3 | suspended | Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery |
| NCT07293351 | CA266-0008 2025-523637-26, U1111-1327-6332 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) |
| NCT02496208 | NCI-2014-02379 NCI-2014-02379, 15-C-0160 | Ph 1 | active not recruiting | Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors |
| NCT01896999 | NCI-2013-01275 NCI-2013-01275, E4412 | Ph 1, Ph 2 | active not recruiting | Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT04317105 | NCI-2020-01917 NCI-2020-01917, NCI10221 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN |
| NCT04840589 | NCI-2021-02850 NCI-2021-02850, HCC#21-211 | Ph 1 | suspended | Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors |
| NCT03866382 | NCI-2019-01266 NCI-2019-01266, A031702 | Ph 2 | recruiting | Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors |
| NCT03502733 | NCI-2017-02249 NCI-2017-02249, NCI CC 18-C-0122 | Ph 1 | active not recruiting | Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma |
| NCT03816358 | NCI-2019-00242 NCI-2019-00242, PJC-026 | Ph 1 | active not recruiting | Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer |
| NCT03793166 | NCI-2018-03694 NCI-2018-03694, A031704 | Ph 3 | active not recruiting | Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study |
| NCT05904080 | NCI-2023-04469 NCI-2023-04469, A092105 | Ph 2 | recruiting | Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer |
| NCT04929041 | NCI-2021-06042 NCI-2021-06042, A082002 | Ph 2, Ph 3 | suspended | Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative |
| NCT03604978 | NCI-2018-01560 NCI-2018-01560, 201901009 | Ph 1, Ph 2 | active not recruiting | Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma |
| NCT03816345 | NCI-2019-00241 NCI-2019-00241, 10204 | Ph 1 | recruiting | Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO |
| NCT02339571 | NCI-2014-02674 NCI-2014-02674, EA6141 | Ph 2, Ph 3 | active not recruiting | A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma |
| NCT02834013 | NCI-2016-01041 NCI-2016-01041, S1609 | Ph 2 | active not recruiting | Nivolumab and Ipilimumab in Treating Patients With Rare Tumors |
| NCT02314169 results posted | NCI-2014-02420 NCI-2014-02420, NCI9673 | Ph 2 | active not recruiting | Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer |
| NCT04464759 LIMIT | UPCC 01620 IRB#835033 | Ph 1, Ph 2 | recruiting | A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma |
| NCT07128680 | 25160 NCI-2025-05679, 25160 | Ph 1 | recruiting | Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer |
| NCT06594991 | 24-166 | Ph 2 | recruiting | A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma |
| NCT07291076 | CA266-0006 2025-523602-33, U1111-1327-4912 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) |
| NCT05647265 | A082101 NCI-2022-09320, U10CA180821 | Ph 2 | recruiting | Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma |
| NCT07430202 | J2622 IRB00541955 | Ph 1 | not yet recruiting | A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC) |
| NCT03122522 | 17-162 | Ph 2 | active not recruiting | A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy |
| NCT04462406 | EA6192 NCI-2020-04463, EA6192 | Ph 2 | active not recruiting | Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial |
| NCT03769155 | IRB00104273 NCI-2018-01229, Winship4400-18 | Ph 1 | active not recruiting | VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma |
| NCT05012254 NIVIPI-Brain | GECP 21/02_NIVIPI-Brain 2021-000425-27 | Ph 2 | active not recruiting | Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases |
| NCT04003649 | 18251 NCI-2018-02764, 18251 | Ph 1 | active not recruiting | IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM |
| NCT06941857 | J2541 IRB00486324 | Ph 2 | recruiting | NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer |
| NCT05144529 TOP2101 results posted | Pro00109594 W81XWH-21-1-0532 | Ph 2 | terminated | A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC |
| NCT01274338 results posted | NCI-2011-02649 NCI-2011-02649, CDR0000692568 | Ph 3 | active not recruiting | Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery |
| NCT07166406 | NRG-GI012 NCI-2025-05951, NRG-GI012 | Ph 3 | recruiting | Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial |
| NCT04145115 | NCI-2019-07242 NCI-2019-07242, A071702 | Ph 2 | active not recruiting | A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden |
| NCT02506153 results posted | NCI-2014-02676 NCI-2014-02676, S1404 | Ph 3 | active not recruiting | Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery |
| NCT05327686 SAMURAI | NRG-GU012 NCI-2022-02189, NRG-GU012 | Ph 2 | recruiting | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial |
| NCT05536141 ARC-20 | ARC-20 2024-519142-70-00 | Ph 1 | recruiting | A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors |
| NCT07188896 | HCRN GU23-651 | Ph 2 | recruiting | A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC) |
| NCT04751370 | NCI-2021-00912 NCI-2021-00912, EA2201 | Ph 2 | active not recruiting | Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer |
| NCT04472767 | 20205807 UCI 19-49 | Ph 2 | recruiting | Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma |
| NCT01708941 results posted | NCI-2012-01932 NCI-2012-01932, CDR0000741878 | Ph 2 | active not recruiting | Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery |
| NCT03816332 results posted | NCI-2019-00239 NCI-2019-00239, ETCTN10214 | Ph 1 | active not recruiting | Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers |
| NCT03799445 results posted | 2018-0381 NCI-2018-03260, 2018-0381 | Ph 2 | terminated | Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma |
| NCT02890329 results posted | NCI-2016-01326 NCI-2016-01326, 17-718 | Ph 1 | active not recruiting | Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia |
| NCT03521830 | J1866 IRB00166274, CA209-8DP | Ph 2 | recruiting | Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma |
| NCT02879695 results posted | NCI-2016-01300 NCI-2016-01300, ETCTN10030 | Ph 1 | active not recruiting | Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia |
| NCT03789110 results posted | 18-561 | Ph 2 | active not recruiting | NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer |
| NCT06889493 | 20231325 | Ph 1 | recruiting | SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET) |
| NCT01134614 results posted | NCI-2011-02039 NCI-2011-02039, CDR0000671238 | Ph 2 | active not recruiting | Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery |
| NCT06097728 eVOLVE-Meso | D7988C00001 2023-503231-17-00, 2023-000067-32 | Ph 3 | recruiting | MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma |
Showing 50 of 572 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
YERVOY FDA Label Details
Indications & Usage
FDA Label (PDF)YERVOY is indicated for the treatment of Unresectable or metastatic melanoma; Adjuvant treatment of cutaneous melanoma with regional lymph node involvement following complete resection; Intermediate or poor risk advanced renal cell carcinoma; Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer; Unresectable or metastatic hepatocellular carcinoma; Metastatic non-small cell lung cancer expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations; Metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations; Unresectable malignant pleural mesothelioma; Unresectable advanced esophageal cancer.
Pro Intelligence Preview
Deep insights for YERVOY
Revenue Insights
- • Q4-2025: $810M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2025
- • Generic/biosimilar risk
Trial Analysis
- • 576 total trials
- • Stage: Stable
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment