Final Data From Calm: A Phase Ii Study Of Coxsackievirus A21 (Cva21) Oncolytic Virus Immunotherapy In Patients With Advanced Melanoma.

9030 Background: CVA21 (CAVATAK) is a novel bio-selected oncolytic and immunotherapeutic strain of Coxsackievirus A21. Intratumoral (i.t) CVA21 injection initiates preferential tumor cell infection, cell lysis and enhancement of a systemic anti-tumor immune response. Presented are the final data of the open-label, multicenter Phase II CALM (CAVATAK in Late stage Melanoma) study. Methods: The CALM study investigated the efficacy and safety of i.t CVA21 in 57 patients with treated or untreated unresectable Stage IIIC-IVM1c melanoma. Pts received up to 3 x 108 TCID50CVA21 i.t on study days 1,3,5, 8 and 22, and then every three weeks for a further 6 injections. Pts displaying immune-related progression-free survival (irPFS) or better at 6 mos were eligible for 9 additional injections. Key eligibility criteria were ≥ 18 yrs old, ECOG PS 0-1, and at least 1 injectable cutaneous, subcutaneous, or nodal melanoma metastasis ≥ 1.0 cm. The primary endpoint was to achieve u003e 9 of 54 evaluable pts with irPFS at 6 mos. ...