Table 1.

Phase I/II clinical trials for MSLN-targeted immunotherapies

AgentPhaseInterventionCancer/s targetedStatus/resultsClinicaltrials.gov IdentifierReferences
CRS-207IIGVAX and cyclosphosphamide with or without CRS-207Metastatic pancreatic cancer31% SD, 51% PDNCT01417000(36)
II BCRS-207 alone or plus GVAX therapy and cyclophosphamideMetastatic pancreatic cancerRecruitingNCT02004262
I BCRS-207 plus pemetrexed and cisplatin with and without cyclophosphamideMesotheliomaRecruitingNCT01675765
ICRS-207 aloneMesothelioma, pancreatic adenocarcinoma, NSCLC, ovarian adenocarcinomaDose-dependent evidence of immune activationNCT00585845(35)
Immunotoxin SS1PISS1P plus pemetrexed and cisplatinMesothelioma77% PR, 8% SD, 15% PDNCT01445392(42)
ISS1P plus pentostatin and cyclophosphamideMesothelioma30% PR, 30% SD, 40% PDNCT01362790(41)
ISS1P treatment plus carboplatin, paclitaxel, and bevacizumabNSCLCClosedNCT01051934
ISS1P alone, continuous infusionOvarian, pancreatic, mesothelioma4% PR, 50% SD, 46% PDNCT00006981(89)
ISS1P alone, bolus infusionOvarian, pancreatic, mesothelioma12% PR, 58% SD, 30% PDNCT00066651(40)
Amatuximab (MORAb-009)IIAmatuximab plus pemetrexed and cisplatinMesothelioma40% PR, 51% SDNCT00738582(45)
IIAmatuximab plus gemcitabinePancreatic cancerNo objective responseNCT00570713
IAmatuximab aloneColorectal, pancreatic, head and neck, mesothelioma18% SD, 82% PDNCT01018784(90)
IAmatuximab alonePancreatic, mesothelioma, ovarian55% SD, 45% PDNCT00325494(91)
BAY 94-9343IBAY 94-9343 aloneInvasive ovarian cancer, primary peritoneal, fallopian tube cancer, mesothelioma, and other cancersRecruitingNCT01439152
NCT02485119
CAR T cellsI/IICAR T cells plus fludarabine, cyclophosphamide, and aldesleukinMetastatic cancers, pancreatic cancer, mesothelioma, ovarianRecruitingNCT01583686
ICAR T cells plus cyclophosphamideMetastatic pancreatic ductal adenocarcinoma, epithelial ovarian cancer, mesotheliomaRecruitingNCT02159716
ICAR T cells aloneMetastatic pancreatic ductal adenocarcinomaCompletedNCT01897415
ICAR T cells aloneMesotheliomaCompletedNCT01355965
ICAR T cells plus cyclophosphamide plus CD19-CAR T cellsPancreatic cancerRecruitingNCT02465983
ICAR T cells plus cyclophosphamideMesothelioma, metastatic lung, and breast cancersRecruitingNCT02414269

Abbreviations: NSCLC, non–small cell lung cancer; PD, progressive disease; PR, partial response; SD, stable disease.