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 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 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


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, evaluated per RECIST


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%)


Bevacizumab+everolimus does not improve responses compared to bevacizumab alone, but selected patients with alterations in the PI3K/mTOR pathway may have benefit


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

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