Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody Durvalumab (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers

Trial ID # NCT02484404
Phase I/II
Drug Class Angiogenesis Inhibitors: VEGFR
Drug Name Cediranib
Alternate Drug Names Recentin, Cediranib maleate, AZD2171
Drugs in Trial Cediranib, Durvalumab, Olaparib
Eligible Participant

Advanced or recurrent ovarian cancer refractory to standard treatment

Patients Enrolled

318 [ovarian: Phase I: Ced+Dur: 9 (4 Pt-S, 5 Pt-R); Ced+Dur+Ola: 7 (2 Pt-S, 5 Pt-R)]

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, RP2D, evaluated per RECIST


Exploratory: PD-L1 protein


RP2D: 1500mg Dur q28d +20 mg Ced 5 days on/2 days off
ORR: 42.9% (3PR, n=7) (3 Pt-S)
DCR (4 months): 71.4% (3PR, 2SD, n=7) (4Pt-S, 1 Pt-R)

RP2D: 1500mg Dur q28d + 300mg Ola bid + 20 mg Ced 5 days on/2 days off
ORR: 42.9% (3PR, n=7)(1 Pt-S BRCA MUT, 2 Pt-R BRCA WT)
DCR: 71.4% (3PR, 2SD, n=7) (2 Pt-R BRCA WT w/ SD for 19, 21 months)
DoR: 8.5 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: hypertension (17%), fatigue (17%)
Serious AE: none
Grade 3-4 AE: lymphopenia (11%), anemia (11%), hypertension (11%)


Promising response rates for cediranib, durvalumab and olaparib combinations


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

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

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