A Randomized, Open-Label, Multicenter, Phase 3 Study To Evaluate The Efficacy And Safety Of Avelumab (MSB0010718C) In Combination With And/Or Following Chemotherapy In Patients With Previously Untreated Epithelial Ovarian Cancer Javelin Ovarian 100

Trial ID # NCT02718417; JAVELIN Ovarian 100
Phase III
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name Avelumab
Alternate Drug Names Anti programmed death ligand 1 monoclonal antibody, Anti-PD-L1, MSB0010718C, Bavencio
Drugs in Trial Avelumab, Carboplatin, Paclitaxel
Eligible Participant

Newly diagnosed stage III/IV ovarian cancer (neo-adjuvant or adjuvant and maintenance)

Patients Enrolled


Therapy Setting


Study Design

Open-Label, Randomized


ORR, PFS, evaluated per RECIST


CarboPt+Pac+Ave+Ave maint vs CarboPt+Pac+Ave maint vs CarboPt+Pac:

ORR: 36.0 vs 30.4 vs 30.4%
PFS: 18.1 vs 16.8 vs NR months; HR: 1.14 (0.83-1.56, p=0.79); HR: 1.43 (1.05-1.95 p=0.99)

Clinically Significant Adverse Events

CarboPt+Pac+Ave+Ave maint vs CarboPt+Pac+Ave maint vs CarboPt+Pac:
Serious AE: overall (36 vs 28 vs 19%)
Grade 3-4 AE: overall (70.8 vs 66.5 vs 62.6%), neutropenia (30 vs 28 vs 6%)


Avelumab addition to carboplatin+paclitaxel and/or continued as maintenance therapy for newly diagnosed ovarian cancer patients does not improve PFS; PD-L1, CD8, and gBRCA1/2 status did not predict differential clinical benefit


Monk BJ et al. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. Lancet Oncol (2021) 22(9):1275-1289

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