Phase II Randomized Study Comparing Imatinib With or Without Atezolizumab in Adults With Advanced Gastrointestinal Stromal Tumors After Standard Treatment Failure

What this Trial Is About

Researchers are evaluating treatments for patients with unresectable advanced gastrointestinal stromal tumors GIST who have not responded to standard therapies including imatinib, sunitinib, and regorafenib. This phase II, randomized, multicenter trial compares whether combining the drug atezolizumab with imatinib improves disease control, specifically progression-free survival, compared to imatinib alone. The study also considers patients tumor genetic status to better understand treatment outcomes. Participants are randomly assigned to one of two treatment groups one group receives imatinib daily along with intravenous infusions of atezolizumab every three weeks for up to 12 months, and the other group receives imatinib alone daily for the same duration. The trial includes an interim safety analysis and will monitor progression-free survival as the primary measure. Statistical methods will compare outcomes between groups, considering tumor mutation status. During the study, participants will have regular assessments including imaging to measure tumor response, monitoring of side effects, and quality of life evaluations. Researchers will track progression-free survival over 48 months and other outcomes such as overall survival, response rates, treatment failure time, and tolerability. Data will be securely recorded and monitored according to clinical standards, and participants will be followed closely throughout the study period.

A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments