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, recurrent or refractory ovarian cancer, ≥ 2 prior therapies, no prior anti-PD-1 Ab

Patients Enrolled

20

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% (1CR,1PR, n=10)
ORR (all doses): 15% (1CR, 2PR, n=20)
DCR: 45% (1CR, 2PR, 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