The K-MASTER cancer precision medicine diagnosis and treatment enterprise (K-MASTER project) is a precision medicine cancer treatment clinical trial platform, which uses next-generation sequencing (NGS) panel to screen the actionable mutations in 10,000 patients with refractory solid tumors and assigns the patients to matched clinical trials. K-MASTER project was initiated in Korea in June 2017. From October 2017, we have analyzed NGS -based cancer panel to detect genomic variations in Korean cancer patients. Tumor DNA was analyzed by K-MASTER panel, which allows to detect variations of 375 genes. As of September 3, 2019, total 4,240 cancer patients were registered via KM-00 screening protocol. The mean depth of K-MASTER panel was 701x. The patient whose cancer has been confirmed of certain genomic variants can participate in matched clinical studies. As of September 2019, 11 clinical trials are successfully in process and another 6 are awaiting kickoff under the name of K-MASTER project. There are 3 ongoing immunotherapy clinical trials: avelumab for metastatic colon cancer with microsatellite instability-high or POLE mutation (KM-01), nivolumab for advanced solid tumor with DNA repair pathway aberration (KM-06), and spartalizumab combined with lacnotuzumab for esophageal squamous cell carcinoma (KM-12). Among them, the KM-01 study closed its registration and is waiting for data analysis. Other studies are actively enrolling patients along with KM-00 screening protocol. In addition, various new immunotherapy studies are preparing for initiation: basket trial of nivolumab plus ipilimumab for high tumor mutational burden solid tumors (KM-09), phase II study of CAST cell therapy (KM-15), alternative scheduling trial for pembrolizumab (KM-19), and phase II/III trial of novel PD-1 inhibitor INCMGA00012 (KM-20) are on their way to start. In conclusion, K-MASTER project is efficient to detect actionable variations and function as a reliable path between patient and new immunotherapeutic agent. Nationwide NGS-based screening is not only feasible but also effective in recruiting participants in molecular basket trials as well as immunotherapy trials. This novel knowledge provides an intriguing background to investigate new target approaches and to progress precision medicine. (This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute [KHIDI], funded by the Ministry of Health &Welfare, Republic of Korea [Grant number: HI17C2206].)

Citation Format: Ju Won Kim, Jae Sook Sung, Hee Jun Jung, Jung Yoon Choi, Soo Hyeon Lee, Won Jin Chang, Yoon Ji Choi, Kyong Hwa Park, Yeul Hong Kim. Cancer immunotherapy clinical trials in K-MASTER project [abstract]. In: Proceedings of the AACR Special Conference on Tumor Immunology and Immunotherapy; 2019 Nov 17-20; Boston, MA. Philadelphia (PA): AACR; Cancer Immunol Res 2020;8(3 Suppl):Abstract nr A34.