Ipilimumab
證據等級: L5 | 預測適應症: 2 個
## 藥師評估報告
Ipilimumab (易乳莫單抗) - 藥師評估報告
一句話總結
易乳莫單抗是一種抗 CTLA-4 免疫檢查點抑制劑，TxGNN 預測其對非皮膚黑色素瘤有療效，這項預測獲得大量臨床試驗支持，展現了極高的轉譯價值。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥物學名 | Ipilimumab |
| 台灣商品名 | 益伏注射劑 5 毫克/毫升 (YERVOY) |
| DrugBank ID | DB06186 |
| 原核准適應症 | 無法切除或轉移性黑色素瘤、腎細胞癌、NSCLC、肝細胞癌、大腸直腸癌、食道癌等（多與 nivolumab 併用） |
| 預測新適應症 | metastatic melanoma、choroideremia |
| 最高證據等級 | L1/L2 (多項 RCT 研究) |
| 台灣上市狀態 | 有效許可證 |
預測適應症詳細分析
1. choroideremia L5 99.06% 主要分析
為什麼這個預測合理？
Ipilimumab 透過阻斷 CTLA-4 來增強 T 細胞活化，解除免疫系統對腫瘤的抑制：
- 非皮膚黑色素瘤 (TxGNN Score: 0.990, Rank: 16733)：
- 包括黏膜黑色素瘤、眼部黑色素瘤（葡萄膜黑色素瘤）等
- 這些亞型較皮膚黑色素瘤少見，但具有相似的免疫原性
- Ipilimumab（特別是與 nivolumab 併用）已在這些亞型中顯示療效
- 脈絡膜無虹膜症 (Choroideremia) (TxGNN Score: 0.991, Rank: 16090)：
- 這是一種遺傳性視網膜退化疾病，非腫瘤性
- 此預測的機轉關聯不明，可能為偽陽性
臨床試驗
目前無針對此特定適應症的臨床試驗登記。
2. non-cutaneous melanoma L1 99.02%
臨床試驗（50 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT05302921 | PHASE2 | COMPLETED | 5 | Phase II Study Investigating the Efficacy of Neoadjuvant Dual Checkpoint Inhibit... |
| NCT01827111 | PHASE2 | COMPLETED | 21 | Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma |
| NCT01621490 | PHASE1 | COMPLETED | 170 | An Exploratory Study of the Biologic Effects of Nivolumab and Ipilimumab Monothe... |
| NCT04074967 | PHASE1, PHASE2 | ACTIVE_NOT_RECRUITING | 70 | A Phase Ib/II Study of ARRY-614 Plus Either Nivolumab or Nivolumab+Ipilimumab in... |
| NCT01940809 | PHASE1 | TERMINATED | 15 | A Sequential Safety and Biomarker Study of BRAF-MEK Inhibition on the Immune Res... |
| NCT02659540 | PHASE1 | COMPLETED | 20 | A Pilot (Phase 1) Study to Evaluate the Safety and Efficacy of Combination Check... |
| NCT04107168 | N/A | UNKNOWN | 1800 | An Observational Study to Evaluate the Microbiome as a Biomarker of Efficacy and... |
| NCT02992912 | PHASE2 | ACTIVE_NOT_RECRUITING | 138 | A Phase II Study to Assess the Efficacy of the Anti-PD-L1 Antibody Atezolizumab ... |
| NCT01840007 | PHASE2 | COMPLETED | 20 | Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma |
| NCT05584670 | PHASE1, PHASE2 | RECRUITING | 542 | A Phase 1/2, Open Label, First-in-human, Dose Escalation and Expansion Study for... |
| NCT04418167 | PHASE1 | SUSPENDED | 71 | A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in ... |
| NCT03999749 | PHASE2 | ACTIVE_NOT_RECRUITING | 71 | A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combinat... |
| NCT06880198 | NA | RECRUITING | 20 | An Interventional, Not Pharmacological Study to Evaluate Impact® as Support to A... |
| NCT01838200 | PHASE1 | TERMINATED | 5 | A Phase I Study of Intralesional Bacillus Calmette-Guerin (BCG) and Followed by ... |
| NCT02073123 | PHASE1, PHASE2 | COMPLETED | 132 | A Phase 1/2 Study of the Concomitant Administration of Indoximod Plus Immune Che... |
| NCT03509584 | PHASE1 | TERMINATED | 6 | Phase I Multicenter Trial Combining Nivolumab, Alone or With Ipilimumab, Plus Hy... |
| NCT02224768 | N/A | COMPLETED | 158 | YERVOY Risk Minimisation Tool Evaluation Survey |
| NCT01608594 | PHASE1 | COMPLETED | 30 | Neoadjuvant Combination Biotherapy With Ipilimumab (3 mg/kg or 10 mg/kg) and Hig... |
| NCT03618641 | PHASE2 | COMPLETED | 34 | Neoadjuvant Phase II Study of TLR9 Agonist CMP-001 in Combination With Nivolumab... |
| NCT03220009 | PHASE2 | WITHDRAWN | 0 | A Randomized Phase II Trial of Adjuvant Nivolumab or Expectant Observation Follo... |
| NCT04988841 | PHASE2 | COMPLETED | 70 | Prospective randomIzed Clinical Trial Assessing the Tolerance and Clinical Benef... |
| NCT06581406 | PHASE2, PHASE3 | RECRUITING | 280 | A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety... |
| NCT04605146 | NA | RECRUITING | 100 | Impact of Telemonitoring for the Management of Side Effects in Patients with Mel... |
| NCT04899921 | PHASE2 | TERMINATED | 1 | A Blinded, Randomized Phase 2 Study of Troriluzole in Combination With Ipilimuma... |
| NCT00796991 | PHASE1 | COMPLETED | 72 | A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + C... |
| NCT01973608 | PHASE2 | TERMINATED | 12 | A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in... |
| NCT04860076 | N/A | UNKNOWN | 400 | Open-label, Uncontrolled, Non-Interventional, Retrospective Study to Evaluate Mo... |
| NCT00972933 | EARLY_PHASE1 | COMPLETED | 59 | Neoadjuvant Anti-CTLA4 Blockade With Ipilimumab in Patients With AJCC Stage IIIB... |
| NCT04940299 | PHASE2 | ACTIVE_NOT_RECRUITING | 35 | A Phase II Study to Assess the Safety and Efficacy of Tocilizumab in Combination... |
| NCT01363206 | PHASE2 | COMPLETED | 29 | GM-CSF and Ipilimumab as Therapy in Metastatic Melanoma, a Phase II Study |
| NCT04866810 | NA | SUSPENDED | 24 | The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN) |
| NCT00871481 | PHASE1, PHASE2 | COMPLETED | 10 | Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic M... |
| NCT06999980 | PHASE2 | NOT_YET_RECRUITING | 494 | A Phase II, Multicentre, Parallel Group, Open Label, Randomised Clinical Trial o... |
| NCT01323517 | PHASE2 | COMPLETED | 26 | A Phase II Trial of The Addition of Ipilimumab (MDX-010) To Isolated Limb Infusi... |
| NCT06295159 | PHASE2 | RECRUITING | 90 | Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Me... |
| NCT01496807 | PHASE1 | COMPLETED | 31 | A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages I... |
| NCT03348891 | NA | COMPLETED | 60 | TNF in Melanoma Patients Treated With Immunotherapy |
| NCT02009384 | PHASE2 | TERMINATED | 2 | A Phase II Open-Label Study of Ipilimumab Administered to Stage IIIC and Stage I... |
| NCT03126110 | PHASE1, PHASE2 | COMPLETED | 145 | A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN0187... |
| NCT03458455 | N/A | UNKNOWN | 200 | Improved Therapy Response Assessment in Metastatic Brain Tumors |
| NCT05428007 | PHASE2 | RECRUITING | 105 | A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combinatio... |
| NCT04951583 | PHASE2 | ACTIVE_NOT_RECRUITING | 45 | Phase II Trial of Fecal Microbial Transplantation in Patients With Advanced Non-... |
| NCT05384496 | PHASE2 | RECRUITING | 20 | Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Additio... |
| NCT03469960 | PHASE3 | COMPLETED | 265 | A Randomized Phase 3 Trial Comparing Continuation Nivolumab-Ipilimumab Doublet I... |
| NCT06116461 | PHASE4 | RECRUITING | 34 | Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Respo... |
| NCT00162123 | PHASE2 | COMPLETED | 248 | A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treat... |
| NCT01708941 | PHASE2 | ACTIVE_NOT_RECRUITING | 88 | A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Com... |
| NCT02626962 | PHASE2 | COMPLETED | 52 | Phase II Multicenter, Non Randomized, Open Label Trial of Nivolumab in Combinati... |
| NCT01709162 | PHASE2 | TERMINATED | 31 | A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment V... |
| NCT01844505 | PHASE3 | COMPLETED | 945 | A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab ... |
相關文獻（5 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 24999899 | 2014 | Article | The Medical journal of Austral | Ipilimumab in pretreated patients with unresectable or metastatic cutaneous, uve... |
| 28183255 | 2018 | Article | Current cancer drug targets | Melanoma Adjuvant Treatment: Current Insight and Clinical Features. |
| 29466692 | 2018 | Article | Discovery medicine | Anti-programmed cell death-1 (PD-1) monoclonal antibodies in treating advanced m... |
| 37887546 | 2023 | Article | Current oncology (Toronto, Ont | Effectiveness of Immune Checkpoint Inhibitor with Anti-PD-1 Monotherapy or in Co... |
| 40236344 | 2025 | Article | Cureus | A Case Report of Metastatic Melanoma in the Transverse Colon. |
台灣上市資訊
有效許可證：
| 許可證字號 | 商品名 | 許可證持有者 | 效期 |
|---|---|---|---|
| 衛部菌疫輸字第000958號 | 益伏注射劑 5 毫克/毫升 | 台灣必治妥施貴寶 | 2029/08/18 |
核准適應症（與 nivolumab 併用）：
- 無法切除或轉移性黑色素瘤（12 歲以上）
- 晚期腎細胞癌（中度/重度風險）
- MSI-H/dMMR 轉移性大腸直腸癌
- 肝細胞癌（第一線和 sorafenib 失敗後）
- 轉移性或復發性非小細胞肺癌
- 惡性肋膜間皮瘤
- 食道鱗狀細胞癌
安全性考量
免疫相關不良事件 (irAEs)
Ipilimumab + Nivolumab 併用療法的 Grade 3-4 irAEs 發生率約 50-60%：
| 不良反應類型 | 常見表現 | 管理重點 |
|---|---|---|
| 腸炎 | 腹瀉、血便 | 可能需 corticosteroids |
| 肝炎 | 轉氨酶升高 | 監測肝功能 |
| 皮膚炎 | 皮疹、搔癢 | 外用/全身性 steroids |
| 內分泌病變 | 甲狀腺/腎上腺功能異常 | 荷爾蒙補充 |
| 肺炎 | 呼吸困難、咳嗽 | 停藥並給予 steroids |
| 腸穿孔 | 罕見但致命 | 緊急外科介入 |
主要藥物交互作用
| 交互作用藥物 | 嚴重程度 | 說明 |
|---|---|---|
| Corticosteroids | Moderate | 可能降低免疫治療效果 |
| Hydrocortisone | Moderate | 用於 irAEs 管理時需權衡 |
| Dexamethasone | Moderate | 同上 |
| 其他免疫抑制劑 | Moderate | 可能影響療效 |
特殊族群
- 肝功能不全：輕度肝功能不全不需調整劑量
- 腎功能不全：不需調整劑量
- 孕婦：禁用，可能致畸
- 老年患者：毒性可能增加，需密切監測
藥物-疾病注意事項 (DDSI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
Hepatic Insufficiency 🟡 Moderate
- 可能有嚴重不良反應。
Pneumonia 🟡 Moderate
- 必要時應停止治療。
Colitis 🟢 Minor
- 風險包括：感染。可能有致命風險。必要時應停止治療。
Dermatitis 🟢 Minor
- 出現症狀時應考慮停藥。
Endocrine System Diseases 🟢 Minor
- 需定期監測。可能危及生命。出現症狀時應考慮停藥。
Hepatitis 🟢 Minor
- 需定期監測。可能有致命風險。出現症狀時應考慮停藥。
Graft vs Host Disease 🟢 Minor
- 需密切監測。可能有致命風險。
Immune System Diseases 🟢 Minor
- 需定期監測。可能有致命風險。出現症狀時應考慮停藥。
Eye Diseases 🟢 Minor
- 需定期監測。可能有致命風險。出現症狀時應考慮停藥。
結論與下一步
預測評估結論
Ipilimumab 對非皮膚黑色素瘤的預測是高度有價值的發現：
- 葡萄膜黑色素瘤：已有 Phase 2 試驗數據，顯示與 nivolumab 併用的療效
- 黏膜黑色素瘤：多項進行中的臨床試驗正在評估
- 脈絡膜無虹膜症：此預測缺乏機轉支持，可能為偽陽性
證據等級總結
| 預測適應症 | TxGNN Score | 證據等級 | 評估 |
|---|---|---|---|
| 非皮膚黑色素瘤 | 0.990 | L1/L2 | 多項 RCT 支持，極高價值 |
| 脈絡膜無虹膜症 | 0.991 | L5 | 機轉不明，可能偽陽性 |
建議
- 非皮膚黑色素瘤：
- 強烈建議持續追蹤臨床試驗進展
- 現有 Phase 2 試驗（NCT02626962）結果已發表
- 可作為臨床決策參考
- 部分亞型可能已可在仿單外使用條件下應用
- 適應症擴增建議：
- 葡萄膜黑色素瘤和黏膜黑色素瘤的證據已相對成熟
- 可考慮向 TFDA 提交適應症擴增申請
- 臨床應用注意事項：
- 非皮膚黑色素瘤預後通常較皮膚型差
- 需謹慎評估病患狀況和 irAEs 風險
- 建議在有免疫治療經驗的中心使用
報告生成日期：2026-02-11 資料來源：TxGNN 知識圖譜預測、ClinicalTrials.gov、PubMed、台灣 FDA
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引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Ipilimumab老藥新用驗證報告. https://twtxgnn.yao.care/drugs/ipilimumab/
BibTeX 格式：
@misc{twtxgnn_ipilimumab,
title = {Ipilimumab老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/ipilimumab/}
}
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
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