Phase II Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer An Investigator-initiated, Single-institution Trial at Magee-Womens Hospital

Trial ID #	NCT01031381
Phase	II
Drug Class	Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR
Drug Name	Everolimus
Alternate Drug Names	Afinitor, Certican, RAD001, Zortress
Drugs in Trial	Everolimus, Bevacizumab
Eligible Participant	Recurrent ovarian cancer
Patients Enrolled	50, median of 3 prior therapies (1-10); 30 Pt-S, 18 Pt-R/Rf, 2 unknown
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, evaluated per RECIST
Efficacy	ORR: 15.2% (1CR, 6PR, n=46) DCR: 91.3% (1CR, 6PR, 35SD, n=46) PFS: 3.7 months PFS (at 6 months): 24% 2 clear cell w/ PI3K pathway and ARID1A alterations (1PR, 1SD > 9 months) Exploratory analysis, Pt-status, tumor profiling: Pt-S (n=30): ORR: 16.7% (1CR, 4PR) Pt-R (n=18): ORR: 11.1% (2PR) - 1PR in Pt-Rf patient
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: overall (50%)
Conclusion	Everolimus+bevacizumab does not improve responses compared to bevacizumab alone, but selected patients with alterations in the PI3K/mTOR pathway may have benefit
Reference	Taylor, SE et al. Phase II study of everolimus and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer. Gynecol Oncol (2020) 156(1):32-37 https://www.ncbi.nlm.nih.gov/pubmed/31739991