A Phase II Study With a Safety lead-in of Nivolumab in Combination With Bevacizumab or in Combination With Bevacizumab and Rucaparib for the Treatment of Relapsed Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Trial ID #	NCT02873962
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, Bevacizumab
Eligible Participant	Partially platinum sensitive, or resistant ovarian cancer, no prior immune checkpoint inhibitor
Patients Enrolled	38 [20 Pt-S; median 1 prior therapy (1-3); 17 BRCA WT, 3 BRCA unk; 18 Pt-R; median 2 prior therapies (1-3); 2 BRCA MUT, 12 BRCA WT, 4 BRCA unk]
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	CBR, ORR, DCR, PFS, evaluated per RECIST
Efficacy	ORR: 28.9% (11PR,1uPR, n=38) DCR: 78.9% (11PR, 1uPR,19SD, n=38) CBR: 52.6% (11PR, 1uPR, 9SD, n=38) PFS: 9.4 months Exploratory analysis Pt status: Pt-S (n=20): ORR: 40% (8PR, 1uPR); DCR: 85% (8PR, 1uPR, 9SD), CBR: 70% (8PR, 1uPR, 6SD), PFS: 12.1 months Pt-R (n=18): ORR: 16.7% (3PR); DCR: 72.2% (3PR, 10SD), CBR: 33.3% (3PR, 3SD), PFS: 7.7 months
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: all (23.9%)
Conclusion	Nivolumab+bevacizumab shows activity in Pt-R patients
Reference	Liu JF et al. Assessment of Combined Nivolumab and Bevacizumab in Relapsed Ovarian Cancer: A Phase 2 Clinical Trial. JAMA Oncol (2019) 5(12):1731-1738 https://www.ncbi.nlm.nih.gov/pubmed/31600397