Ipilimumab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-IPILIMUMAB |
|---|---|
| Type | Drug |
| Aliases | YervoyІпілімумаб |
| Status | reviewed 2026-04-27 | pending_clinical_signoff |
| Diseases | DIS-ESOPHAGEAL DIS-MELANOMA DIS-MESOTHELIOMA DIS-NSCLC DIS-RCC |
| Sources | SRC-ESMO-MELANOMA-2024 SRC-NCCN-MELANOMA-2025 |
Drug Facts
| Class | Anti-CTLA-4 monoclonal antibody (immune checkpoint inhibitor) |
|---|---|
| Mechanism | Fully human IgG1κ monoclonal antibody targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4 / CD152), an inhibitory checkpoint receptor expressed on activated T cells and constitutively on regulatory T cells (Tregs). By blocking CTLA-4 / B7 (CD80/CD86) engagement at the T-cell priming stage in lymph nodes, ipilimumab releases an early brake on T-cell activation and expands the anti-tumor T-cell repertoire; the IgG1 isotype also depletes intratumoral Tregs via Fc-mediated ADCC. Mechanism is complementary and non-redundant with anti-PD-1 (which acts at the effector phase in the tumor microenvironment), giving clear efficacy gains in combination but also markedly increased irAE burden. Historical first-in-class ICI (FDA 2011 melanoma — Hodi NEJM 2010, first OS-prolonging therapy in metastatic melanoma). Pivotal combination trials: CheckMate-067 (nivo+ipi vs nivo vs ipi melanoma 1L... |
| Typical dosing | Melanoma 1L combo: ipilimumab 3 mg/kg IV over 90 minutes every 3 weeks × 4 doses + nivolumab 1 mg/kg IV q3w × 4 doses (induction), then nivolumab monotherapy 240 mg q2w or 480 mg q4w until progression / toxicity / 24 mo. RCC 1L combo: ipilimumab 1 mg/kg + nivolumab 3 mg/kg IV q3w × 4 doses, then nivo mono. Mesothelioma / MSI-H mCRC / HCC / NSCLC 1L combos: per protocol-specific schedules (typically 1 mg/kg q3w or q6w with nivolumab). Adjuvant melanoma monotherapy: 10 mg/kg q3w × 4 then q12w up to 3 yr (largely superseded by nivolumab adjuvant). No formal renal or hepatic dose adjustment (mAb catabolism). Hold for G2-3 irAE; permanently discontinue for G4 irAE, myocarditis, recurrent G3 desp... |
| Ukraine registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Warnings
- Severe and fatal immune-mediated adverse reactions — colitis, hepatitis, dermatitis (SJS/TEN), neuropathy, endocrinopathies; can occur during or after ipilimumab; substantially more frequent and more severe than with anti-PD-1 alone
Notes
CTLA-4 irAE pattern differs from PD-1: earlier onset (often within first cycle), more colitis, more hypophysitis, less pneumonitis / thyroiditis (vs PD-1). Cumulative cycle count rather than ongoing exposure drives toxicity (because of long half-life and IgG1 effector functions); after 4-cycle induction the irAE risk trajectory continues for weeks-to-months. Hypophysitis is often permanent — patients require lifelong corticosteroid + thyroid hormone replacement. Baseline workup before any combo with anti- PD-1: TFTs, LFTs, creatinine, cortisol (AM), HbA1c, lipase / amylase, troponin if cardiac risk, HBV/HCV, CT chest, dermatologic exam. Monitor TFTs / LFTs / creatinine / cortisol before each cycle for first 4 cycles then before each nivo dose. Hospitalize early and treat aggressively with high-dose IV methylprednisolone for any G3-4 irAE; escalate to infliximab / mycophenolate / IVIG / ATG for steroid-refractory. Cross-disease entity: ipilimumab is used in melanoma (1L combo nivo, adjuvant mono superseded by nivo), RCC (1L combo nivo intermediate/poor risk), MSI-H/dMMR CRC (combo nivo), HCC (combo nivo post sorafenib), mesothelioma (1L combo nivo), NSCLC (1L combo nivo ± chemo), e...
Used By
Regimens
REG-IPI-NIVO-ESOPH-SCC- Nivolumab + ipilimumab (ESCC, 1L metastatic; CheckMate-648)REG-NIVO-IPI-CHEMO-NSCLC-1L- Nivolumab + Ipilimumab + 2-Cycle Platinum-Doublet Chemotherapy (CheckMate-9LA)REG-NIVO-IPI-MELANOMA- Nivolumab + ipilimumab (melanoma, 1L metastatic)REG-NIVO-IPI-MESOTHELIOMA- Nivolumab + ipilimumab (mesothelioma, 1L)REG-NIVO-IPI-RCC- Nivolumab + ipilimumab (RCC, 1L IMDC intermediate/poor)