| Trial ID # | NCT02484404 |
| Phase | I/II |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-L1 |
| Drug Name | Durvalumab |
| Alternate Drug Names | Anti-B7H1 Monoclonal Antibody MEDI4736, MEDI4736, Imfinzi |
| Drugs in Trial | Cediranib, Durvalumab, Olaparib |
| Eligible Participant | Advanced or recurrent ovarian cancer refractory to standard treatment |
| Patients Enrolled | 318 [ovarian: Phase I: Dur+Ced: 9 (4 Pt-S, 5 Pt-R); Dur+Ola+Ced: 7 (2 Pt-S, 5 Pt-R); Phase II: Dur+Ola: 35, median of 3.5 prior therapies (1-16)] |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, RP2D, evaluated per RECIST |
| Biomarkers | Exploratory: PD-L1 protein |
| Efficacy | Dur+Ola: Dur+Ced: Dur+Ola+Ced: |
| Clinically Significant Adverse Events | Dur+Ola: |
| Conclusion | Promising response rates for durvalumab, cediranib and olaparib combinations |
| Reference | Lee, J-M et al. Safety and Clinical Activity of the Programmed Death-Ligand 1 Inhibitor Durvalumab in Combination With Poly (ADP-Ribose) Polymerase Inhibitor Olaparib or Vascular Endothelial Growth Factor Receptor 1-3 Inhibitor Cediranib in Women's Cancers: A Dose-Escalation, Phase I Study. J Clin Oncol (2017) 35(19):2193-2202 Lee J-M et al. A phase II study of durvalumab, a PD-L1 inhibitor and olaparib in recurrent ovarian cancer (OvCa) Ann Oncol (2018) 29 (suppl_8 abstr 936PD) Zimmer AS et al. A phase I study of the PD-L1 inhibitor, durvalumab, in combination with a PARP inhibitor, olaparib, and a VEGFR1-3 inhibitor, cediranib, in recurrent women's cancers with biomarker analyses. J Immunther Cancer (2019) 7(1):197 |