{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T23:07:26Z","timestamp":1791328046570,"version":"4.3.1"},"reference-count":25,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"36","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2008,12,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> The primary objective of this phase I\/II study was to determine the safety and pharmacokinetic profile of either transfectoma- or a hybridoma-derived ipilimumab. Secondary objectives included determination of a maximum-tolerated dose and assessment of clinical activity. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Eighty-eight patients with unresectable stage III or IV melanoma with at least one measurable lesion were treated. Mean age was 59 years, with 65% male and 35% female patients, and 79% of patients had received prior systemic therapy. Single doses of ipilimumab up to 20 mg\/kg (group A, single dose), multiple doses up to 5 mg\/kg (group A, multiple dose), and multiple doses up to 10 mg\/kg (group B) were administered. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Single dosing up to 20 mg\/kg of transfectoma antibody was well tolerated, as were multiple doses up to 10 mg\/kg without a maximum-tolerated dose. In group B, dose-limiting toxicity was seen in six of 23 melanoma patients. Grade 3 or 4 immune-related adverse events (irAEs) were observed in 14% of patients (12 of 88 patients), and grade 1 or 2 irAEs were seen in an additional 58%. The half-life of ipilimumab was 359 hours. In group B, there was one partial response (23+ months), one complete response (21+ months), and seven patients with stable disease (SD), for a disease control rate of 39%. Two patients in group B with SD had slow, steady decline in tumor burden that was ongoing at 1 year of observation. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Ipilimumab has activity in patients with metastatic melanoma. Late responses were observed in patients with prolonged SD. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2008.16.1927","type":"journal-article","created":{"date-parts":[[2008,11,18]],"date-time":"2008-11-18T02:48:35Z","timestamp":1226976515000},"page":"5950-5956","source":"Crossref","is-referenced-by-count":405,"title":["Phase I\/II Study of Ipilimumab for Patients With Metastatic Melanoma"],"prefix":"10.1200","volume":"26","author":[{"given":"Jeffrey S.","family":"Weber","sequence":"first","affiliation":[{"name":"From the University of Southern California\/Norris Comprehensive Cancer Center; The Angeles Clinic and Research Institute, Los Angeles, CA; Robert Franz Cancer Center, Earle A. 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Chiles Research Institute, Portland, OR; the University of Arizona Cancer Center, Tucson, AZ; Carolina Bio-Oncology Institute, Huntersville, NC; and Medarex, Inc, Annadale, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Powderly","sequence":"additional","affiliation":[{"name":"From the University of Southern California\/Norris Comprehensive Cancer Center; The Angeles Clinic and Research Institute, Los Angeles, CA; Robert Franz Cancer Center, Earle A. Chiles Research Institute, Portland, OR; the University of Arizona Cancer Center, Tucson, AZ; Carolina Bio-Oncology Institute, Huntersville, NC; and Medarex, Inc, Annadale, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoff","family":"Nichol","sequence":"additional","affiliation":[{"name":"From the University of Southern California\/Norris Comprehensive Cancer Center; The Angeles Clinic and Research Institute, Los Angeles, CA; Robert Franz Cancer Center, Earle A. 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