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 DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
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

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