Li Zhou, Xiaowen Wu, Zhihong Chi, Lu Si, Xinan Sheng, Yan Kong, Lili Mao, Bin Lian, Bixia Tang, Xieqiao Yan, Xuan Wang, Xue Bai, Siming Li, Xiaoting Wei, Juan Li, Qing Yang, Jun Guo, Chuanliang Cui
Abstract
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.
Pharmacology, Toxicology and Pharmaceutical Science
1
5%
Other
2
9%
Unknown
10
45%
Attention Score in Context
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 May 2022.
All research outputs
#18,146,485
of 23,312,088 outputs
Outputs from BMC Cancer
#5,058
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Outputs of similar age
#296,298
of 440,844 outputs
Outputs of similar age from BMC Cancer
#140
of 294 outputs
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