A Phase I Clinical Trial of NY-ESO-1 Protein Immunization in Combination With 5-AZA-2'-Deoxycytidine (Decitabine) in Patients Receiving Liposomal Doxorubicin for Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Trial ID #	NCT00887796
Phase	I
Drug Class	Immunotherapy: Vaccine/NY-ESO-1
Drug Name	NY-ESO-1 protein / MIS416 vaccine
Drugs in Trial	Decitabine, Liposomal doxorubicin, NY-ESO-1 protein / MIS416 vaccine
Eligible Participant	Relapsed ovarian cancer receiving liposomal doxorubicin
Patients Enrolled	12; median 2 prior therapies
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, DCR, DoR, evaluated per irRECIST
Efficacy	All patients Pt-R: ORR: 10% (1PR, n=10) DCR: 60% (1PR, 5SD, n=10) DoR: 6.3 months (3.9-7.8)
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: neutropenia, injection site reaction
Conclusion	Encouraging anti-tumor activity of chemoimmunotherapy regimen
Reference	Odunsi K et al. Epigenetic potentiation of NY-ESO-1 vaccine therapy in human ovarian cancer. Cancer Immunol Res (2014) 2(1): 37-49 https://www.ncbi.nlm.nih.gov/pubmed/24535937