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	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, OS, evaluated per RECIST
Biomarkers	Exploratory: PD-L1 protein
Efficacy	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%)
Conclusion	Encouraging anti-tumor activity with acceptable safety profile
Reference	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 http://www.ncbi.nlm.nih.gov/pubmed/26351349