A Phase II trial of immunotherapy with an anti-PD-1 antibody in advanced / relapsed, Platinum - resistant Ovarian Cancer

Trial ID # UMIN000005714
Phase II
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 Nivolumab
Eligible Participant

Platinum resistant or refractory ovarian cancer with ≥ 2 prior therapies, no prior anti-PD-1 Ab

Patients Enrolled

20 (15 serous, 3 endometrioid, 2 clear cell)

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, OS, evaluated per RECIST


Exploratory: PD-L1 protein


ORR (1mg/kg): 10% (1PR, n=10)
ORR (3mg/kg): 20% (2CR - 1 serous, 1 clear cell, n=10)
ORR (all doses): 15% (2CR, 1PR, n=20)
DCR: 45% (2CR, 1PR, 6SD, n=20)
PFS: 3.5 months (1.7-3.9)
OS: 20.0 months (7.0-NR)

Clinically Significant Adverse Events

Serious AE: 10%
Grade 3-4 AE: lymphocytopenia (15%), anemia (15%), decreased albumin (10%)


Encouraging anti-tumor activity with acceptable safety profile


Hamanishi et al. Safety and Antitumor Activity of Anti-PD-1 Antibody, Nivolumab, in Patients With Platinum-Resistant Ovarian Cancer. J Clin Oncol (2015) 33(34):4015-22

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