Table 1.
Ongoing clinical trials using the immune checkpoint inhibitors in GC.
| Agent | Trial name/number | Phase | Trial population | Primary end points | Estimated study completion date |
|---|---|---|---|---|---|
| Nivolumab | A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors/NCT01928394 | I/II | Advanced solid tumors including GC | Overall response rate (ORR) | Dec-18 |
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| MEDI4736 Tremelimumab | A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma/NCT02340975 | I-II | GC or GEJ Adenocarcinoma | ORR, PFS, and safety | 17-Aug-18 |
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| Nivolumab/Ipilimumab | Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)/NCT02872116 | III | GC or GEJ Adenocarcinoma | OS | 11-Oct-20 |
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| ONO-4538 (Nivolumab) | Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer/NCT02267343 | III | Unresectable advanced or recurrent GC and GEJ adenocarcinoma | OS | Aug-17 |
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| 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/NCT01375842 | I | Locally advanced/metastatic solid tumor including GC | Dose limited toxicity | 31-May-18 |
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| Nivolumab | An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)/NCT02743494 | III | Resected esophageal and GEJ cancer | DFS/OS | 1-Apr-21 |
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| Avelumab | Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)/NCT01772004 | I | Metastatic or locally advanced solid tumors including GC and GEJ adenocarcinoma | Dose limiting toxicity/best overall response | 31-May-18 |
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| 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)/NCT02370498 | III | Advanced GC and GEJ adenocarcinoma | PFS/OS | Aug-17 |
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| Pembrolizumab (MK-3475) | Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)/NCT01848834 | I | Advanced solid tumors including GC | Adverse events | May-17 |
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| Avelumab | Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)/NCT02625610 | III | Unresectable locally advanced/metastatic GC and GEC adenocarcinoma | OS | 31-Mar-24 |
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| Avelumab | Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)/NCT02625623 | III | Unresectable, recurrent, locally advanced, or metastatic GC and GEH adenocarcinoma | OS | 30-Sep-22 |
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| ONO-4538 (Nivolumab) | Study of ONO-4538 in Gastric Cancer/NCT02746796 | II | Unresectable advanced or recurrent GC and GEJ adenocarcinoma | ORR | Aug-20 |
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| Nivolumab/Ipilimumab | An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358)/NCT02488759 | I/II | Virus-associated tumors including EBV GC | Drug related toxicity, ORR, and rate of surgery delay | Dec-19 |
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| Pembrolizumab | Pembrolizumab, 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/NCT02730546 | I/II | Unresectable locally advanced GC and GEJ adenocarcinoma | Pathological complete remission/PFS | Apr-18 |
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| Pembrolizumab | Pembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer/NCT02901301 | I/II | HER2 positive GC | ORR | Mar-18 |
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| 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)/NCT02494583 | III | Advanced GC and GEJ adenocarcinoma | PFS/OS | 6-Jun-20 |
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| 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)/NCT02564263 | III | EGJ adenocarcinoma | PFS/OS | 31-Aug-18 |
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| 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)/NCT02335411 | II | Advanced GC and GEJ adenocarcinoma | Drug related toxicity/ORR | Jun-18 |
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| MEDI4736 | Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM)/NCT02678182 | II | Locally advanced or metastatic HER2 positive or HER2 negative oesophagogastric adenocarcinomas | PFS | Feb-20 |