AustralieFrV1, Main, Exploration, bibRecord, 007641

Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed Melanoma

Identifieur interne : 007641 ( Main/Exploration ); précédent : 007640; suivant : 007642

Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed Melanoma

Auteurs : John M. Kirkwood [États-Unis] ; Paul Lorigan [Royaume-Uni] ; Peter Hersey [Australie] ; Axel Hauschild [Allemagne] ; Caroline Robert [France] ; David Mcdermott [États-Unis] ; Margaret A. Marshall [États-Unis] ; Jesus Gomez-Navarro [États-Unis] ; Jane Q. Liang [États-Unis] ; Cecile A. Bulanhagui [États-Unis]

Source :

Clinical cancer research [ 1078-0432 ] ; 2010.

RBID : Pascal:10-0144902

Descripteurs français

Pascal (Inist)
- Essai clinique phase II, Homme, Trémélimumab, Malade, Stade avancé, Résistance traitement, Récidive, Mélanome malin.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Human, Malignant melanoma, Patient, Phase II trial, Relapse, Treatment resistance, Tremelimumab.

Abstract

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 M_1c 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.

Affiliations:

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Le document en format XML

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<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Pfizer Global Research & Development</s1>
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<series><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2010">2010</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Human</term>
<term>Malignant melanoma</term>
<term>Patient</term>
<term>Phase II trial</term>
<term>Relapse</term>
<term>Treatment resistance</term>
<term>Tremelimumab</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term>
<term>Homme</term>
<term>Trémélimumab</term>
<term>Malade</term>
<term>Stade avancé</term>
<term>Résistance traitement</term>
<term>Récidive</term>
<term>Mélanome malin</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">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 M<sub>1c</sub>
 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.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Connecticut</li>
<li>Grand Manchester</li>
<li>Massachusetts</li>
<li>Pennsylvanie</li>
<li>Schleswig-Holstein</li>
</region>
<settlement><li>Kiel</li>
<li>Manchester</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
</region>
<name sortKey="Bulanhagui, Cecile A" sort="Bulanhagui, Cecile A" uniqKey="Bulanhagui C" first="Cecile A." last="Bulanhagui">Cecile A. Bulanhagui</name>
<name sortKey="Gomez Navarro, Jesus" sort="Gomez Navarro, Jesus" uniqKey="Gomez Navarro J" first="Jesus" last="Gomez-Navarro">Jesus Gomez-Navarro</name>
<name sortKey="Liang, Jane Q" sort="Liang, Jane Q" uniqKey="Liang J" first="Jane Q." last="Liang">Jane Q. Liang</name>
<name sortKey="Marshall, Margaret A" sort="Marshall, Margaret A" uniqKey="Marshall M" first="Margaret A." last="Marshall">Margaret A. Marshall</name>
<name sortKey="Mcdermott, David" sort="Mcdermott, David" uniqKey="Mcdermott D" first="David" last="Mcdermott">David Mcdermott</name>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name>
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</country>
<country name="Australie"><noRegion><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</region>
</country>
<country name="France"><noRegion><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
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Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed Melanoma

Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed Melanoma

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri