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 Bevacizumab, Temsirolimus
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

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