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A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma Re...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-003265-16

A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma Revised Protocol 2, incorporating Amendments 2 and 7 - version 5.0, dated 28-Sep-07 + Protocol Amendment 01-Pharmacogenetics Blood Sample; + Protocol Amendment 03-Pharmacogenomics Tissue Sample; + Protocol Amendment 04-Pharmacogenomic Biomarker Sample. + Amendment 5 Country Specific - Germany - version 1.0, dated 04-Apr-06 + Amendment 6 Country Specific - Germany - version 1.0, dated 11-Aug-06

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Extrait

To estimate best overall response rate (BORR) (as per modified WHO criteria) in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.

Critère d'inclusion

  • Previously treated unresectable Stage III or IV Melanoma

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