Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study.

Publication date: May 20, 2022

Anti-programmed cell death receptor-1 (PD-1) monotherapy is the standard treatment for metastatic melanoma in current. Camrelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody whose safety and efficacy have not been reported in advanced Asian melanoma patients. This phase I study investigated the safety, activity, and pharmacokinetics of camrelizumab in Chinese patients with advanced melanoma. The study included two phases, the dose-escalation phase (“3 + 3” design at 60 mg, 200 mg, and 400 mg) and the dose-expansion phase. No dose-limiting toxicities were recorded over the dose-escalation phase, and the maximum tolerated dose was not reached. The most common treatment-related adverse events (TRAEs) in 36 patients were reactive cutaneous capillary endothelial proliferation, followed by rash, fever, hypothyroidism, hyperthyroidism, vitiligo, and fatigue. Five grade 3 or above TRAEs were reported (13. 9%), including two cases of elevated γ-glutamyltransferase and blood triglycerides without clinical symptoms, and one liver injury recovered after symptomatic treatment. The confirmed overall response rate was 13. 9% (95%CI: 4. 7, 29. 5%) and disease control rate was 38. 9% (95%CI: 23. 1, 56. 5%). The median progression-free survival was 1. 8 months (95%CI: 1. 1, 2. 4) and the median overall survival was 11. 1 months (95%CI: 6. 8, 15. 4). Camrelizumab had acceptable tolerability and similar anti-tumor activity compared with other anti-PD-1 antibodies in advanced Asian melanoma patients. ClinicalTrials. gov identification: NCT02738489. Registered on 14/04/2016, prospectively registered.

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Concepts Keywords
400mg
Chinese
Free
Pharmacokinetics
Tumor

Semantics

Type Source Name
drug DRUGBANK Guanosine
drug DRUGBANK Bismuth subgallate
drug DRUGBANK Gold
disease MESH nasopharyngeal carcinoma
drug DRUGBANK Cisplatin
drug DRUGBANK Gemcitabine
disease MESH capillary hemangiomas
drug DRUGBANK Diethylstilbestrol
drug DRUGBANK Decitabine
drug DRUGBANK Ranitidine
drug DRUGBANK Pemetrexed
drug DRUGBANK Carboplatin
drug DRUGBANK Indoleacetic acid
disease MESH treatment failure
drug DRUGBANK Esomeprazole
disease MESH Hypertriglyceridemia
disease MESH growth
disease MESH pneumonia
disease MESH weight loss
disease MESH musculoskeletal pain
drug DRUGBANK Fenamole
disease MESH metastasis
drug DRUGBANK Honey
drug DRUGBANK Ilex paraguariensis leaf
disease MESH hyperglycemia
disease MESH hypophysitis
disease MESH nephritis
disease MESH hepatitis
disease MESH pancreatitis
disease MESH aseptic meningitis
disease MESH colitis
disease MESH uveitis
drug DRUGBANK Trestolone
disease MESH noma
disease MESH carcinoma
disease MESH squamous carcinoma
disease MESH lung cancer
pathway KEGG Hepatocellular carcinoma
disease MESH hepatocellular carcinoma
drug DRUGBANK Ipilimumab
disease MESH Carcinogenesis
drug DRUGBANK Coenzyme M
drug DRUGBANK Pembrolizumab
drug DRUGBANK Nivolumab
disease MESH death
disease MESH tumor
disease MESH vitiligo
disease MESH hyperthyroidism
disease MESH hypothyroidism
pathway REACTOME Programmed Cell Death
pathway KEGG Melanoma
disease MESH melanoma

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