Review Article

Immunotherapy in Gastrointestinal Cancers

Table 2

Ongoing studies on colorectal cancers.

NCT identifierSettingPhaseStudy interventionsNumber of patientsPrimary endpoint

Checkpoint inhibitors
NCT03026140Early stage colon cancerIINivolumab + ipilimumab versus nivolumab + ipilimumab + celecoxib60Safety
NCT02260440Chemorefractory mCRCIIPembrolizumab + azacitidine40ORR
NCT02997228MSI-H mCRCIIImFOLFOX6 bevacizumab versus atezolizumab versus atezolizumab + mFOLFOX6 bevacizumab439PFS
NCT02870920Chemorefractory mCRCIIBSC + durvalumab + tremelimumab versus BSC180OS
NCT02788279Chemorefractory mCRCIIIAtezolizumab versus cobimetinib + atezolizumab versus regorafenib360OS
NCT02991196mCRCIDS-8273a + nivolumab20DLTs; MTD; ORR; DCR; TTP; PFS;
NCT02713373Unresectable mCRCI-IICetuximab + pembrolizumab42PFS; ORR; safety and tolerability
NCT02981524mCRCIICY/GVAX + pembrolizumab30ORR
NCT02754856mCRC with resectable CLMITremelimumab + MEDI4736 + FOLFOX bevacizumab35Feasibility
NCT02933944RAS mutmCRCITG02 versus TG02+ pembrolizumab20Safety; irORR
NCT02860546MSS mCRCIITAS-102 + nivolumab35irORR
NCT02948348Locally advanced RCI-IIChemoradiotherapy with capecitabine → nivolumab → surgical therapy50PCR
NCT02437071mCRC
IIPembrolizumab+ radiotherapy versus pembrolizumab+ ablation48ORR
NCT02060188 (CheckMate 142)mCRCIINivolumab/nivolumab + ipilimumab/nivolumab + ipilimumab 1st line/nivolumab + ipilimumab + cobimetinib/nivolumab + BMS-986016/nivolumab + daratumumab260ORR
NCT02512172mCRCIOral CC, 486 & MK-3475 versus romidepsin & MK-3475, versus oral CC, 486 & romidepsin & MK-347530Degree of change in TIL
NCT02227667mCRCIIMEDI473648ORR
NCT02563002 (KEYNOTE 177)MSI-H mCRCIIIPembrolizumab versus
investigator's choice of standard of care
270PFS

Vaccines
NCT02448173Stage IIIIIOncoVAX + surgery versus surgery550DFS
NCT01890213Stage IIIIAVX70112AE
NCT02718430mCRC with CLMIVXM0124Safety and tolerability
NCT01741038mCRCII-IIIAlloStim® + cryoablation versus AlloStim + physician's choice (PC)450OS
NCT02615574Refractory mCRCIIáDC1 vaccine+ CKM44OS

Cytokines
NCT02415699Stage III
II-IIIDC-CIK + chemotherapy versus chemotherapy100DFS
NCT02280278Stage IIIIIIAdjuvant CT → CIKCC versus adjuvant CT550DFS
NCT01929499Stages II-IIIIIAdjuvant CT + synchronous CIKCC versus adjuvant CT → CIKCC versus adjuvant CT210DFS
NCT02466906Stage IIIIIRhGM-CSF versus placebo60DFS
Oncolytic virus
NCT01274624KRASIIREOLYSIN® + FOLFIRI, bevacizumab32DLTs
NCT01622543mCRCIIFOLFOX + bevacizumab + reolysin versus FOLFOX + bevacizumab109PFS
Adoptive cell therapy study
NCT03008499mCRCI-IIHigh-activity natural killer versus no special treatment18Relief degree of tumours evaluated by RECIST
NCT02577588mCRCIReactivated T cells10DLTs

Adjuvant therapy
NCT01545141Resectable CRC
I-IISurgery versus chemokine modulatory regimen (a combination of IFN, celecoxib, and rintatolimod prior to surgery50Change in the number of tumour-infiltrating CD8+ cells

Immune modulators therapy
NCT02077868 (IMPALA)mCRCIIIMaintenance versus MGN1703540OS
NCT02413853 (PRIMIER)mCRCIIPRI-724 + mFOLFOX6/bevacizumab versus mFOLFOX6/bevacizumab100PFS

GC, gastric cancer; GEJC, gastroesophageal junction cancer; EC: esophageal cancer; NA, not assessed; MTD, maximum tolerated dose; MAD, maximum administered dose; DTL, dose limiting toxicity; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; DFS, disease-free survival; NS, not specified; RP2D, recommended dose of phase II; AE, adverse events; DCR, disease control rate; BSC, best supportive care; DCR disease control rate.