Table 1.

Ongoing clinical trials evaluating the combination use of epigenetic drugs and immunotherapy

Clinical trial identifierTitleRecruitment statusEpigenetic drugImmunotherapyDate
EUDRACT 2015-001329-17A phase Ib, open-label, dose-escalation study investigating different doses of guadecitabine in combination with ipilimumab in unresectable or metastatic melanoma patientsNot yet recruitingGuadecitabine (s.c.)aIpilimumabNot submitted
NCT01834248DEC-205/NY-ESO-1 fusion protein CDX-1401 and decitabine in treating patients with myelodysplastic syndrome or AMLRecruitingDecitabine (i.v.)DEC-205/NY-ESO-1 fusion protein CDX-1401 (s.c. and i.d.) and PolyICLC (s.c.)First received: April 12, 2013Last updated: January 15, 2015Last verified: January 2015
NCT01928576Phase II anti–PD-1 epigenetic priming study in NSCLC(NA_00084192)RecruitingAzacitidine (s.c.) and entinostat (p.o.) or CC-486 (oral azacitidine) alone (p.o.)NivolumabFirst received: August 21, 2013Last updated: August 23, 2013Last verified: August 2013
NCT01038778Entinostat in combination with aldesleukin in treating patients with metastatic kidney cancerRecruitingEntinostat (p.o.)Aldesleukin (i.v.)First received: December 18, 2009
Last updated: February 18, 2015
Last verified: December 2014
NCT02332889Phase I/II: decitabine/vaccine therapy in relapsed/refractory pediatric high-grade gliomas/medulloblastomas/CNS PNETsNot yet recruitingDecitabine (i.v.)Vaccine (autologous DC pulsed with pooled, overlapping peptide mixes derived from full-length MAGE-A1, MAGE-A3, and NY-ESO-1) and hiltonol (PolyICLC) (i.m.)First received: October 20, 2014Last updated: January 5, 2015Last verified: January 2015
NCT01483274Decitabine and vaccine therapy for patients with relapsed AML following allogeneic stem cell transplantationNot yet recruitingDecitabineDonor lymphocyte infusion and dendritic cells pulsed with peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3First received: November 3, 2011Last updated: December 1, 2014Last verified: December 2014
NCT01673217Decitabine, vaccine therapy, and PEGylated liposomal doxorubicin hydrochloride in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancerCompletedDecitabine (i.v.) PEGylated liposomal doxorubicin hydrochloride (i.v.)NY-ESO-1 peptide vaccine emulsified in incomplete Freund adjuvant and sargramostim (s.c.)First received: August 22, 2012Last updated: January 10, 2014Last verified: January 2014
NCT01241162Decitabine followed by a cancer antigen vaccine for patients with neuroblastoma and sarcomaRecruitingDecitabine (i.v.)Autologous DC vaccine pulsed with overlapping peptide mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3 with hiltonol (PolyICLC)First received: November 15, 2010Last updated: December 17, 2014Last verified: December 2014
NCT01258868Tumor cell vaccines with ISCOMATRIX adjuvant and celecoxib in patients undergoing resection of lung and esophageal cancers and malignant pleural mesotheliomasRecruitingDecitabine for preparation of autologous cellular vaccineEpigenetically modified autologous tumor cell vaccines with ISCOMATRIX (patient tumor cells exposed to decitabine, exposed to radiation and emulsified in ISCOMATRIX adjuvant) (i.m.)First received: December 10, 2010Last updated: February 20, 2015Last verified: February 2015
NCT01966289Guadecitabine in combination with an allogeneic colon cancer cell vaccine (GVAX) and cyclophosphamide (CY) in metastatic colorectal cancer (mCRC)Not yet open for participant recruitmentGuadecitabine (s.c.)Allogeneic colon cancer cell vaccine (GVAX) (i.d.) and cyclophosphamide (i.v.)First received: October 10, 2013Last updated: October 16, 2013Last verified: October 2013

Abbreviations: CNS, central nervous system; PNET, primitive neuroectodermal tumor.

  • aAdministration route: i.d., intradermal; i.m., intramuscular; i.v., intravenous; p.o., per os; s.c., subcutaneous.