Dose definition and activity evaluation study of the tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein in combination with Dacarbazine in patients with metastatic melanoma

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-005737-11

Femme et Homme

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Extrait

Phase IIa part: - To establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of DTIC in patients with metastatic melanoma, the preliminary tolerability profile of the combination. Phase IIb part: - To evaluate objective response rate (ORR) after 8 cycles (week 24)


Critère d'inclusion

  • Histologically or cytologically confirmed unresectable metastatic (stage IV) non-uveal melanoma