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Nivolumab

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IDDRUG-NIVOLUMAB
ArtArzneimittel
Aliase
OpdivoOpdualag (with relatlimab)Ніволумаб
Statusreviewed 2026-04-26 | pending_clinical_signoff
ErkrankungenDIS-CHL DIS-ESOPHAGEAL DIS-GASTRIC DIS-HCC DIS-HNSCC DIS-MELANOMA DIS-MESOTHELIOMA DIS-NSCLC DIS-RCC
QuellenSRC-NCCN-ESOPHAGEAL-2025 SRC-NCCN-GASTRIC-2025 SRC-NCCN-HCC-2025

Drug Facts

KlasseAnti-PD-1 vollständig humaner IgG4 monoklonaler Antikörper (Immun-Checkpoint-Inhibitor)
VerfahrenFully human IgG4 monoclonal antibody binding programmed cell death protein 1 (PD-1) on activated T cells, blocking the inhibitory PD-1/PD-L1 and PD-1/PD-L2 interactions and restoring cytotoxic T-cell antitumor responses. IgG4 backbone with a stabilizing S228P hinge mutation minimizes ADCC. Mechanistically equivalent to pembrolizumab; combined with anti-CTLA-4 (ipilimumab) the dual blockade amplifies T-cell priming and effector activity at the cost of substantially increased irAE rates. Combined with relatlimab (anti-LAG-3) in Opdualag for melanoma. Approved as monotherapy or combination across many solid tumors and classical Hodgkin lymphoma.
Typische DosierungStandard adult monotherapy: 240 mg IV q2w OR 480 mg IV q4w (over 30 min). Pediatric melanoma adjuvant (≥12 yrs, ≥40 kg): 240 mg q2w; <40 kg: 3 mg/kg q2w. With ipilimumab (1L melanoma, RCC, MSI-H CRC): nivolumab 1 mg/kg + ipilimumab 3 mg/kg q3w × 4 doses, then nivolumab 240 mg q2w or 480 mg q4w maintenance. CheckMate-649 (gastric 1L + chemo): 360 mg q3w with chemo or 240 mg q2w. CheckMate-577 (adjuvant esophageal post-CROSS without pCR): 240 mg q2w × 16 wks, then 480 mg q4w to total 1 year. Treatment until progression, unacceptable toxicity, or specified duration (1 yr adjuvant; 2 yrs metastatic in some indications).
Ukraine registriertWahr
NSZU erstattetWahr
Ukraine zuletzt überprüft2026-04-27

Warnungen

Anmerkungen

CheckMate-577: adjuvant nivolumab × 1 yr in patients with residual ypT+ or ypN+ post-CROSS — DFS approximately doubled (median 22.4 vs 11.0 mo). CheckMate-649: 1L gastric / GEJ / esophageal adenocarcinoma with FOLFOX or CAPOX — OS benefit in CPS ≥5 (FDA + EMA approvals restrict to CPS ≥5 / CPS ≥1 respectively). Combination with ipi amplifies irAE rates substantially: melanoma combo Grade 3-4 irAE ~45-55% vs 15-20% mono. ICI-class management protocols apply uniformly (baseline TFTs/cortisol/LFTs, serial labs, prompt steroid intervention for Grade ≥2 irAE).

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