An Open Label Pilot Study of the NovoTTF-100L(O) System (NovoTTF Therapy) (200 kHz) Concomitant With Weekly Paclitaxel for Recurrent Ovarian Carcinoma

Trial ID #	NCT02244502; INNOVATE-3
Phase	II
Drug Class	Cell Cycle Inhibitors: Other
Drug Name	TTfields
Alternate Drug Names	NovoTTF-100L(O)
Drugs in Trial	Paclitaxel, TTfields
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	31, median 4 prior therapies (1-11); 16% w/ prior bevacizumab
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, PFS, evaluated per RECIST
Efficacy	ORR: 25% (7PR, n=28) DCR: 71% (7PR, 13SD, n=28) PFS: 8.9 months PFS (6 months): 81%
Clinically Significant Adverse Events	Serious AE: none related to TTfields Grade 3-4 AE: none related to TTfields Skin toxicity (rash or irritation) related to TTfields were seen in 90% (mostly Grade 1-2)
Conclusion	TTfields in combination with weekly paclitaxel is well tolerated and shows encouraging responses
Reference	Vergote I et al. Tumor Treating Fields in combination with paclitaxel in recurrent ovarian carcinoma: Results of the INNOVATE pilot study. Gynecol Oncol (2018) 150(3):471-477 https://www.ncbi.nlm.nih.gov/pubmed/30060963