- Title
- Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma
- Creator
- Kirkwood, John M.; Lorigan, Paul; Hersey, Peter; Hauschild, Axel; Robert, Caroline; McDermott, David; Marshall, Margaret A.; Gomez-Navarro, Jesus; Liang, Jane Q.; Bulanhagui, Cecile A.
- Relation
- Clinical Cancer Research Vol. 16, Issue 3, p. 1042-1048
- Publisher Link
- http://dx.doi.org/10.1158/1078-0432.CCR-09-2033
- Publisher
- American Association for Cancer Research
- Resource Type
- journal article
- Date
- 2010
- Description
- Purpose: This phase II study assessed the antitumor activity of tremelimumab, a fully human, anti–CTL-associated antigen 4 monoclonal antibody, in patients with melanoma. Experimental Design: Patients with refractory/relapsed melanoma received 15 mg/kg tremelimumab every 90 days. After 4 doses, patients with tumor response or stable disease were eligible to receive ≤4 additional doses. Primary endpoint was best overall tumor response assessed by an independent endpoint review committee, and secondary endpoints included duration of response, overall survival, progression-free survival, and safety. Results: Of 251 patients enrolled, 246 (241 response-evaluable) received tremelimumab. Objective response rate was 6.6% (16 partial responses); duration of response was 8.9 to 29.8 months. Eight (50%) objective responses occurred in patients with stage IV M₁c disease, and 11 (69%) were ongoing at last tumor assessment. Eight (3.3%) patients achieved responses in target lesions (Response Evaluation Criteria in Solid Tumors) despite progressive disease within the first cycle. All 8 survived for >20 months; 5 (63%) remained alive. Clinical benefit rate (overall response + stable disease) was 21% (16 partial responses and 35 stable disease), and median overall survival was 10.0 months. Progression-free survival at 6 months was 15%, and survival was 40.3% at 12 months and 22% at 24 months. Common treatment-related adverse events were generally mild to moderate, and grade 3/4 adverse events included diarrhea (n = 28, 11%), fatigue (n = 6, 2%), and colitis (n = 9, 4%). There were 2 (0.8%) treatment-related deaths. Conclusions: Tremelimumab showed an objective response rate of 6.6%, with all responses being durable ≥170 days since enrollment, suggesting a potential role for tremelimumab in melanoma.
- Subject
- tremelimumab; melanoma; patients; tumor responses
- Identifier
- http://hdl.handle.net/1959.13/931609
- Identifier
- uon:11117
- Identifier
- ISSN:1078-0432
- Language
- eng
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