| Trial ID # | NCT02785250; DeCidE1 |
| Phase | Ib/II |
| Drug Class | Immunotherapy: Vaccine/Survivin |
| Drug Name | Maveropepimut-S |
| Alternate Drug Names | survivin antigen vaccine DPX-Survivac, DPX-Survivac |
| Drugs in Trial | Cyclophosphamide, Epacadostat, Maveropepimut-S |
| Eligible Participant | Recurrent ovarian cancer |
| Patients Enrolled | 67 [Phase Ib: 53; median 4 prior therapies; 34% Pt-S, 66% Pt-R; Phase II: 22; median 3 prior therapies (1-8); 59% Pt-R] |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | CBR, ORR, DCR, PFS, OS, evaluated per irRECIST |
| Efficacy | Phase Ib: Exploratory analysis: Baseline Tumor Burden (BTB): Phase 2: Exploratory analysis: Baseline Tumor Burden (BTB): |
| Clinically Significant Adverse Events | Serious AE: none |
| Conclusion | Encouraging anti-tumor activity of immunotherapy combination. Active immune response in all assayed patients; correlation seen between T cell infiltration and tumor regression response |
| Reference | Tanyi JL et al. DPX-Survivac and intermittent low-dose cyclophosphamide (CPA) with or without epacadostat (E) in the treatment of subjects with advanced recurrent epithelial ovarian cancer (DeCidE1 trial): T cell responses and tumor infiltration correlate with tumor regression. J Clin Oncol (2019) 37 (suppl; abstr 5576) Tanyi JL et al. Poster Dorigo O et al. Infiltration of tumor by T cells following treatment with DPX-Survivac and intermittent low dose cyclophosphamide (CPA) leads to clinical responses in advanced recurrent ovarian cancer (OvCa). J Clin Oncol (2020) 38: (suppl; abstr 6075) Dorigo O et al. Poster Dorigo O et al. Maveropepimut-S, a DPX-based immune-educating therapy, shows promising and durable clinical benefit in patients with recurrent ovarian cancer, a phase 2 trial. Clin Cancer Res (2023) 29(15):2808-2815 |