{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T08:53:22Z","timestamp":1790931202396,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["20ck0106622h0001"],"award-info":[{"award-number":["20ck0106622h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Comprehensive genomic profiling (CGP) tests can identify putative biomarkers for immune checkpoint inhibitors (ICIs), including tumor mutational burden (TMB); however, their clinical utility remains uncertain. In this study, the efficacy and safety of nivolumab treatment based on the CGP results were investigated using a subcohort from the BELIEVE trial (NCCH1901; jRCTs031190104). This trial aims to improve drug accessibility for patients with advanced solid tumors harboring actionable genetic variants through off\u2010label drug administration. Patients for whom off\u2010label nivolumab treatment was proposed based on CGP results were eligible. Nivolumab was administered until disease progression or unacceptable toxicity. The primary endpoint was the best objective response rate (ORR) in patients with measurable disease. Secondary endpoints included progression\u2010free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Among 60 enrolled patients, 56 patients who received study treatment were included in the analysis. TMB\u2010High was the most frequent biomarker prompting nivolumab treatment (47\/56, 83.9%), followed by\n                    <jats:italic>CD274<\/jats:italic>\n                    (PD\u2010L1) amplification (6\/56, 10.7%) and\n                    <jats:italic>CDK12<\/jats:italic>\n                    inactivating variants (3\/56, 5.4%). Among 50 patients with measurable disease, the ORR was 16.0% (95% confidence interval [CI], 7.2\u201329.1) and the DCR was 40.0% (95% CI, 26.4\u201354.8). Median PFS and OS were 2.7\u2009months (95% CI, 2.2\u20134.3) and 7.2\u2009months (95% CI, 4.4\u20139.0), respectively. Although a subset of patients achieved durable responses, nivolumab treatment guided by CGP results demonstrated limited efficacy. The predictive value of TMB\u2010High may differ across tumor types, and integration with other clinicogenomic factors is warranted to improve its predictive accuracy.\n                  <\/jats:p>","DOI":"10.1111\/cas.70463","type":"journal-article","created":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T05:15:09Z","timestamp":1783401309000},"page":"2819-2826","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Phase\n                    <scp>II<\/scp>\n                    Trial of Nivolumab in Advanced Solid Tumors Based on Genomic Profiling:\n                    <scp>BELIEVE<\/scp>\n                    Trial (\n                    <scp>NCCH1901<\/scp>\n                    ) Subcohort"],"prefix":"10.1111","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6954-4474","authenticated-orcid":false,"given":"Masashi","family":"Kanai","sequence":"first","affiliation":[{"name":"Department of Medical 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6694-8414","authenticated-orcid":false,"given":"Ichiro","family":"Kinoshita","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuhiro","family":"Yoshinami","sequence":"additional","affiliation":[{"name":"Center for Cancer Genomics and Personalized Medicine The University of Osaka Hospital  Suita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chigusa","family":"Morizane","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusuke","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Urology and Andrology The University of Tokyo Hospital  Bunkyo\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshio","family":"Kubo","sequence":"additional","affiliation":[{"name":"Cancer for Innovative Clinical Medicine Okayama University Hospital  Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamoru","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Cardiovascular Medicine Kyushu University Hospital  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Nishihara","sequence":"additional","affiliation":[{"name":"Center for Cancer Genomics Keio University School of Medicine  Shinjuku\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8573-418X","authenticated-orcid":false,"given":"Toru","family":"Mukohara","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology National Cancer Center Hospital East  Kashiwa Japan"},{"name":"Department of Genetic Medicine and Services National Cancer Center Hospital East  Kashiwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9154-9004","authenticated-orcid":false,"given":"Hidekazu","family":"Shirota","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Tohoku University Hospital  Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryo","family":"Ko","sequence":"additional","affiliation":[{"name":"Division of Thoracic Oncology Shizuoka Cancer Center  Nagaizumi\u2010cho Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taro","family":"Shibata","sequence":"additional","affiliation":[{"name":"Biostatistics Division, Center for Research Administration and Support National Cancer Center  Tokyo 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