drugset / Trial / NCT03609424

PDR001 Plus Imatinib for Metastatic or Unresectable GIST

NCT03609424

Phase 1/2 Completed 39 enrolled Asan Medical Center Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

Assuming that PDR001, an anti-PD-1 antibody, with imatinib might be effective in advanced GIST after failure of standard TKI therapies including imatinib, sunitinib, and regorafenib. In this phase I/II study of PDR001 plus imatinib, it is aimed to evaluate the safety and efficacy of this regimen as 4th line of treatment in advanced GIST.

Timeline

Start
2019-02-14
Primary completion
2021-11-11
Completion
2021-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 200 mg Oral
Subject Imatinib Small molecule 300 mg Oral
Subject Imatinib Small molecule 400 mg Oral
Subject Spartalizumab Monoclonal antibody 400 mg Intravenous