A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer

Trial ID #	NCT01010126
Phase	II
Drug Class	Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR
Drug Name	Temsirolimus
Alternate Drug Names	Torisel, CCI-779
Drugs in Trial	Temsirolimus, Bevacizumab
Eligible Participant	Recurrent ovarian cancer with ≤ 2 prior chemotherapy regimens
Patients Enrolled	58 patients; 24 Pt-S, 34 Pt-R
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, evaluated per RECIST
Efficacy	ORR: 28.3% (15PR, n=53) DCR: 66.0% (15PR, 20SD, n=53) PFS at 6 months: 49.1% Exploratory analysis, Pt-status: Pt-S (n=25): ORR: 24% (6PR) Pt-R (n=28): ORR: 32.1% (9PR)
Clinically Significant Adverse Events	Serious AE: 1 small intestinal perforation, 1 colonic perforation Grade 3-4 AE: all (63.8%), hypertension (15.5%), infection (13.6%), abdominal pain (10.6%), thrombocytopenia (10.6%), hypokalemia (10.6%)
Conclusion	Temsirolimus+bevacizumab has activity in Pt-R ovarian cancer but with substantial toxicity
Reference	Morgan R et al. A multicenter phase II study of bevacizumab (B) and temsirolimus (T) in women with recurrent epithelial ovarian cancer (OC): A study of the Mayo, Chicago, California, New York, Southeast, and Princess Margaret Phase II Consortia. J Clin Oncol (2013) 31 (suppl; abstr 5517) https://ascopubs.org/doi/abs/10.1200/jco.2013.31.15_suppl.5517 Morgan et al., Poster https://www.clearityfoundation.org/wp-content/uploads/2020/06/TemBev-ASCO-2013.pdf