Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study.
BMC Cancer
; 22(1): 565, 2022 May 20.
Article
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| MEDLINE
| ID: mdl-35596181
ABSTRACT
BACKGROUND:
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.METHODS:
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.RESULTS:
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).CONCLUSIONS:
Camrelizumab had acceptable tolerability and similar anti-tumor activity compared with other anti-PD-1 antibodies in advanced Asian melanoma patients. TRIAL REGISTRATION ClinicalTrials.gov identification NCT02738489. Registered on 14/04/2016, prospectively registered.Palabras clave
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Banco de datos:
MEDLINE
Asunto principal:
Anticuerpos Monoclonales Humanizados
/
Melanoma
Límite:
Humans
Idioma:
En
Año:
2022
Tipo del documento:
Article