Multicenter, open-label, randomized study in patients with ovarian cancer(ONO-4538-23)

Trial ID # JapicCTI-153004; NINJA
Phase III
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name Nivolumab
Alternate Drug Names BMS-936558, ONO-4538, MDX-1106, Anti-PD-1 human mab MDX-1106, Opdivo
Drugs in Trial Gemcitabine, Liposomal doxorubicin, Nivolumab
Eligible Participant

Platinum resistant or refractory ovarian cancer with no prior gemcitabine or liposomal doxorubicin

Patients Enrolled

316; 78% with 2 or more prior therapies

Therapy Setting



PFS, OS, evaluated per RECIST


Niv (n=157) vs Gem/PLD (n=159):

PFS: 2.04 vs 3.84 months, HR: 1.03 (0.80-1.32, p=0.808)
OS: 10.12 vs 12.09 months, HR: 1.46 (1.15-1.85, p=0.002)

Clinically Significant Adverse Events

Niv vs Gem/PLD:
Serious AE: overall (3.8 vs 9.0%)
Grade 3-4 AE: overall (11 vs 65%); anemia (2.6 vs 14%), neutropenia (0.6 vs 40%)


Nivolumab does not improve OS compared with gemcitabine/liposomal doxorubicin in patients with platinum resistant ovarian cancer


Hamanishi J et al. Nivolumab Versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients With Platinum-Resistant Ovarian Cancer: Open-Label, Randomized Trial in Japan (NINJA). J Clin Oncol (2021)

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