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	Liposomal doxorubicin, Nivolumab, Gemcitabine
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	Recurrence
Endpoints	PFS, OS, evaluated per RECIST
Efficacy	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%)
Conclusion	Nivolumab does not improve OS compared with gemcitabine/liposomal doxorubicin in patients with platinum resistant ovarian cancer
Reference	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) 39(33):3671-3681 https://pubmed.ncbi.nlm.nih.gov/34473544/