A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination With Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women With Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab

Trial ID #	NCT04739800; NRG-GY023
Phase	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, Liposomal doxorubicin, Olaparib, Paclitaxel, Topotecan
Eligible Participant	Platinum resistant ovarian cancer with 2- 5 prior therapies; all patients must have had prior bevacizumab
Patients Enrolled	153
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Efficacy	Ola+Ced+Dur (n=44) vs TPC (Pac, PLD, or Top, n=23): PFS: 2.9 vs 4.3 months, HR: 1.142 (0.60-2.18, p=0.55)
Conclusion	The non-chemo triplet of olaparib, cediranib and durvalumab does not improve PFS compared to standard chemotherapy
Reference	Lee J-M et al. Randomized phase II trial of durvalumab in combination with olaparib and cediranib (DOC) compared to olaparib and cediranib (OC) or durvalumab and cediranib (DC) or standard of care chemotherapy (SOC) in platinum-resistant ovarian cancer with prior bevacizumab (NRG-GY023). Ann Oncol (2023) 34(2) abstract 746MO https://www.clearityfoundation.org/wp-content/uploads/2023/11/NRG-GY023-abstract-ESMO-2023.pdf