BioMed Research International / 2017 / Article / Tab 1

Review Article

Immunotherapeutic Strategies for Gastric Carcinoma: A Review of Preclinical and Clinical Recent Development

Table 1

Ongoing clinical trials using the immune checkpoint inhibitors in GC.

AgentTrial name/numberPhaseTrial populationPrimary end pointsEstimated study completion date

NivolumabA Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors/NCT01928394I/IIAdvanced solid tumors including GCOverall response rate (ORR)Dec-18

MEDI4736 TremelimumabA Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma/NCT02340975I-IIGC or GEJ AdenocarcinomaORR, PFS, and safety17-Aug-18

Nivolumab/IpilimumabEfficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)/NCT02872116IIIGC or GEJ AdenocarcinomaOS11-Oct-20

ONO-4538 (Nivolumab)Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer/NCT02267343IIIUnresectable advanced or recurrent GC and GEJ adenocarcinomaOSAug-17

MPDL3280A (Atezolizumab)A Phase 1 Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors/NCT01375842ILocally advanced/metastatic solid tumor including GCDose limited toxicity31-May-18

NivolumabAn Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)/NCT02743494IIIResected esophageal and GEJ cancerDFS/OS1-Apr-21

AvelumabAvelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)/NCT01772004IMetastatic or locally advanced solid tumors including GC and GEJ adenocarcinomaDose limiting toxicity/best overall response31-May-18

Pembrolizumab (MK-3475)A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)/NCT02370498IIIAdvanced GC and GEJ adenocarcinomaPFS/OSAug-17

Pembrolizumab (MK-3475)Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)/NCT01848834IAdvanced solid tumors including GCAdverse eventsMay-17

AvelumabAvelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)/NCT02625610IIIUnresectable locally advanced/metastatic GC and GEC adenocarcinomaOS31-Mar-24

AvelumabAvelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)/NCT02625623IIIUnresectable, recurrent, locally advanced, or metastatic GC and GEH adenocarcinomaOS30-Sep-22

ONO-4538 (Nivolumab)Study of ONO-4538 in Gastric Cancer/NCT02746796IIUnresectable advanced or recurrent GC and GEJ adenocarcinomaORRAug-20

Nivolumab/IpilimumabAn Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358)/NCT02488759I/IIVirus-associated tumors including EBV GCDrug related toxicity, ORR, and rate of surgery delayDec-19

PembrolizumabPembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery/NCT02730546I/IIUnresectable locally advanced GC and GEJ adenocarcinomaPathological complete remission/PFSApr-18

PembrolizumabPembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer/NCT02901301I/IIHER2 positive GCORRMar-18

Pembrolizumab (MK-3475)Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)/NCT02494583IIIAdvanced GC and GEJ adenocarcinomaPFS/OS6-Jun-20

Pembrolizumab (MK-3475)Study of Pembrolizumab (MK-3475) Versus Investigator’s Choice Standard Therapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)/NCT02564263IIIEGJ adenocarcinomaPFS/OS31-Aug-18

Pembrolizumab (MK-3475)A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)/NCT02335411IIAdvanced GC and GEJ adenocarcinomaDrug related toxicity/ORRJun-18

MEDI4736Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM)/NCT02678182IILocally advanced or metastatic HER2 positive or HER2 negative oesophagogastric adenocarcinomasPFSFeb-20

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