A Phase II Evaluation of Pembrolizumab in Combination With IV Bevacizumab and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID # NCT02853318
Phase II
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name Pembrolizumab
Alternate Drug Names Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475
Drugs in Trial Bevacizumab, Cyclophosphamide, Pembrolizumab
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

30, mean of 3.8 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

CBR, ORR, DCR, PFS, evaluated per irRECIST

Efficacy

pembrolizumab 200 mg in combination with bevacizumab 15 mg/kg every 3 weeks and oral cyclophosphamide 50 mg every day

ORR: 43.3% (3CR, 10PR, n=30)
DCR: 93.3% (3CR, 10PR, 15SD, n=30)
CBR: 70% (3CR, 10PR, 8SD, n=30)
PFS: 7.6 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: hypertension (15%)

Conclusion

Pembrolizumab+bevacizumab+cyclophosphamide is well tolerated and demonstrates clinical benefit and durable treatment responses

Reference

Zsiros E et al. Efficacy and Safety of Pembrolizumab in Combination With Bevacizumab and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Ovarian Cancer: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol (2020) 7(1):78-85
https://pubmed.ncbi.nlm.nih.gov/33211063/

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