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A phase I clinical trial in cancer patients was performed in 2006. [11] A phase III trial treating thyroid cancer patients started in March 2011. [12] Lenvatinib was granted orphan drug status for treatment of various types of thyroid cancer that do not respond to radioiodine in the US and Japan in 2012 and in Europe in 2013. [13]
In January 2022, a combination clinical trial of pembrolizumab and NL-201, a de novo protein undergoing a phase I clinical trial in people with advanced, relapsed or refractory solid tumors. [94] In March 2023, Merck reported the results of NRG-GY018, a phase III clinical trial in people with stage three to four or recurrent endometrial carcinoma.
Phase I clinical trial from 2016 has results suggesting an elimination half-life of 11 to 17 days. [16] A 2021 structural and functional analysis suggests a t 1/2 of 238 ± 32 minutes, 30- to 80-times higher than pembrolizumab and nivolumab .
At the pre-specified analysis point when 42 Recurrence-free survival (RFS) events occurred among 157 participants with resected stage IIIC-IV melanoma, 22.4% (24/107) in the mRNA-4157 plus pembrolizumab arm had recurrent disease, and 40% (20/50) in the pembrolizumab arm had recurrent disease, which lead to the well-known saying: mRNA-4157 in ...
Immunotherapy: mechanism of action for Durvalumab, Pembrolizumab, Ipilimumab, Atezolizumab. [20]A phase Ib clinical trial of durvalumab and tremelimumab showed some activity in non-small cell lung cancer (NSCLC) [21] Phase I data in advanced metastatic urothelial bladder (Study 1108) has led to FDA breakthrough therapy designation.
Nivolumab/hyaluronidase, sold under the brand name Opdivo Qvantig, is a fixed-dose combination anti-cancer medication used for the treatment of various forms of cancer. [1] [2] Nivolumab/hyaluronidase contains nivolumab, a programmed death receptor-1 (PD-1)-blocking monoclonal antibody; and hyaluronidase, an endoglycosidase. [1]
Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. [5] [6] [10] Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
Results of a Phase I clinical trial were reported in 2016. [6]In December 2019, enfortumab vedotin was approved in the United States for the treatment of adult patients with locally advanced or metastatic urothelial cancer who had previously received a programmed cell death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.
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