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A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Da...

Mise à jour : Il y a 5 ans
Référence : EUCTR2005-006082-14

A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo. Revised Protocol 04, Incorporates Administrative Letters 01, 02 & 03, Amendment 02, Amendment 06 and Amendment 07. Revised Protocol 06 incorporating Administrative letters 01, 02 & 03, Amendments 02, 06, 07, 08 and 09

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Extrait

To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab vs. dacarbazine with Placebo.

Critère d'inclusion

  • Stage III (Unresectable) or IV Melanoma

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