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 Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Bevacizumab, Nivolumab
Eligible Participant

Partially platinum-sensitive, or resistant ovarian cancer, no prior immune checkpoint inhibitor

Patients Enrolled

38 [20 Pt-S, median 1 prior therapies (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: ORR: 40% (8PR, 1uPR, n=20); DCR: 85% (8PR, 1uPR, 9SD, n=20), CBR: 70% (8PR, 1uPR, 6SD, n=20), PFS: 12.1 months
Pt-R: ORR: 16.7% (3PR, n=18); DCR: 72.2% (3PR, 10SD, n=18), CBR: 33.3% (3PR, 3SD, n=18), PFS: 7.7 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: all (23.9%)

Conclusion

Encouraging activity of bevacizumab+nivolumab combination

Reference

Liu JF et al. Assessment of Combined Nivolumab and Bevacizumab in Relapsed Ovarian Cancer: A Phase 2 Clinical Trial. JAMA Oncol (2019) Oct 10
https://www.ncbi.nlm.nih.gov/pubmed/31600397