Objectives Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This Phase 3 study aims to test the hypothesis that the combination of Olvi-Vec followed by further platinum-doublet chemotherapy is particularly effective against tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer (PRROC) as shown in the Phase 2 VIRO-15 study (table 1). Primary objective is progression-free survival (PFS) by RECIST 1.1 in intent-to-treat population (ITT; all randomly assigned patients). Secondary objectives are: i) objective response rate (ORR) and duration of response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified ITT population), PFS by iRECIST, overall survival (OS), and safety; ii) to determine ORR by the Gynecological Cancer Intergroup (GCIG) CA-125 criteria, and Clinical Benefit Rate [CBR=(CR+PR+SD≥15 weeks)/total number of patients evaluated by RECIST 1.1 or iRECIST]. RECIST & iRECIST response will be assessed by blinded central imaging review (BICR). Additional analyses of efficacy endpoints in modified population are included.
Conclusions Trial in progress: there are no available conclusions at the time of submission.
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