{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T21:16:25Z","timestamp":1793222185810,"version":"4.5.0"},"reference-count":15,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2010,7,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Safety and efficacy of tremelimumab (CP-675,206), a fully human anti-cytotoxic T-lymphocyte\u2013associated antigen 4 (CTLA4) monoclonal antibody, were assessed in patients with treatment-refractory colorectal cancer. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> A single-arm, multicenter, phase II trial was conducted in patients with Eastern Cooperative Oncology Group performance status \u2264 1 and measurable colorectal carcinoma for whom standard treatments for metastatic disease had failed. Patients received 15 mg\/kg tremelimumab intravenously every 90 days until progression. Primary end point was objective response status (per Response Evaluation Criteria in Solid Tumors). Secondary end points included safety, duration of response, progression-free survival, and overall survival. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Forty-seven patients who had received extensive prior therapies (all had received fluoropyrimidines, oxaliplatin, and irinotecan; most [91%] had also received cetuximab) were treated. Grade 3\/4 treatment-related adverse events (AEs) were diarrhea (n = 5; 11%), ulcerative colitis (n = 1; 2%), fatigue (n = 1; 2%), autoimmune thrombocytopenia (n = 1; 2%), and hypokalemia (n = 1; 2%), which resolved spontaneously or with interventions. Six patients discontinued because of an AE; two were considered treatment related. Of 45 response-evaluable patients, 44 did not reach second dose (43 progressive disease; one discontinuation). Twenty-one patients (45%) lived \u2265 180 days after enrollment. One patient (2%; 90% CI, &lt; 1% to 10%) had a stable pelvic mass and substantial regression in an adrenal mass (partial response). This patient received five tremelimumab doses; response duration was 6 months (enrollment to disease progression, 15 months). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Tremelimumab did not demonstrate clinically meaningful single-agent activity in this patient population, although the number of survivors at 6 months and the one patient with confirmed partial response are potentially interesting. Further study of tremelimumab in combination with other agents may be warranted. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2010.28.3994","type":"journal-article","created":{"date-parts":[[2010,5,25]],"date-time":"2010-05-25T02:42:36Z","timestamp":1274755356000},"page":"3485-3490","source":"Crossref","is-referenced-by-count":262,"title":["Phase II Study of the Anti-Cytotoxic T-Lymphocyte\u2013Associated Antigen 4 Monoclonal Antibody, Tremelimumab, in Patients With Refractory Metastatic Colorectal Cancer"],"prefix":"10.1200","volume":"28","author":[{"given":"Ki Y.","family":"Chung","sequence":"first","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ira","family":"Gore","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Fong","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Venook","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen B.","family":"Beck","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prudence","family":"Dorazio","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peggy J.","family":"Criscitiello","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane I.","family":"Healey","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Huang","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesus","family":"Gomez-Navarro","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard B.","family":"Saltz","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; Birmingham Hematology Oncology Association, Birmingham, AL; University of California San Francisco, San Francisco, CA; Pfizer Global Research & Development, New London, CT; and ExecuPharm, King of Prussia, PA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc2051"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1126\/science.271.5256.1734"},{"key":"B3","first-page":"606","volume":"9","author":"Wolf AM","year":"2003","journal-title":"Clin Cancer Res"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-06-2298"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-09-2033"},{"key":"B6","volume-title":"Presented at the 44th Annual Meeting of the American Society of Clinical Oncology","author":"Wallis N"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.01.109"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1958.10501452"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.12.147"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1159\/000227465"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.4161\/hv.2.4.3196"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1007\/s00262-008-0653-8"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2007.02.035"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.04.5716"},{"key":"B16","volume-title":"Presented at the 44th Annual Meeting of the American Society of Clinical Oncology","author":"Weber JS"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2010.28.3994","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T22:30:38Z","timestamp":1653517838000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2010.28.3994"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,7,20]]},"references-count":15,"journal-issue":{"issue":"21","published-print":{"date-parts":[[2010,7,20]]}},"alternative-id":["10.1200\/JCO.2010.28.3994"],"URL":"https:\/\/doi.org\/10.1200\/jco.2010.28.3994","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,7,20]]}}}