Table 1.
Clinical Trials of Immunotherapy in GISTs.
| Year | Title | Trial Phase | Primary End-Point | ClinicalTrials.Gov Identifier |
|---|---|---|---|---|
| 2012 | Phase I Study of Dasatinib in Combination With Ipilimumab for Patients With Advanced Gastrointestinal Stromal Tumor and Other Sarcomas | I | Maximum tolerated dose (MTD) |
NCT01643278 Completed |
| 2012 | A Phase I Trial of Ipilimumab (Immunotherapy) and Imatinib Mesylate (c-Kit Inhibitor) in Patients With Advanced Malignancies | I | MTD |
NCT01738139 Recruiting |
| 2015 | Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery | II | Overall response rate (ORR) |
NCT02500797 Active, not recruiting |
| 2016 | A Randomized Phase 2 Study of Nivolumab Monotherapy Versus Nivolumab Combined With Ipilimumab in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (GIST) | II | ORR |
NCT02880020 Completed |
| 2017 | A Phase II Study of Epacadostat and Pembrolizumab in Patients With Imatinib Refractory Advanced Gastrointestinal Stromal Tumors | II | ORR |
NCT03291054 Completed |
| 2018 | A Phase Ib/II Study of PDR001 Plus Imatinib for Metastatic or Unresectable GIST With Prior Failure of Imatinib, Sunitinib and Regorafenib | I/II | Maximum tolerated dose; Disease control rate |
NCT03609424 Recruiting |
| 2018 | A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®18087 in Subjects With Advanced Neuroendocrine and Gastrointestinal Stromal Tumors (DUET-1) | I | Safety and tolerability profile; MTD |
NCT03411915 Completed |
| 2018 | A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE) | I/II | Maximum tolerated dose; Disease control rate |
NCT03475953 Recruiting |
| 2019 | Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies | Ib | Response (CR or PR) |
NCT04000529 recruiting |
| 2020 | A Phase II, Single Arm Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy—AXAGIST | II | 3-Month Progression-Free Survival (PFSR) Rate |
NCT04258956 Recruiting |