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

ConditionsUnresectable Gastrointestinal Stromal Tumor (GIST)Locally Advanced Gastrointestinal Stromal Tumor (GIST)Metastatic Gastrointestinal Stromal Tumor

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre Leon Berard

About this trial

This trial is a prospective, randomized (1:1 ratio), multicenter, comparative and phase II study, conducted in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of imatinib (disease progression),sunitinib and regorafenib (either disease progression or intolerance)

In the first arm, patients will be treated with imatinib + atezolizumab (experimental arm), whereas in the second arm, patients will be treated with imatinib alone (control arm).

The comparison between this two arms will allow to compare whether or not atezolizumab and imatinib is efficient for disease control, in terms of Progression-Free Survival improvement.

Eligibility criteria

Qualifiers

None

Disqualifiers

Measurable disease, per RECIST v1.1, must be present outside the CNS.

The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.

The patient has not undergone stereotactic radiotherapy within 7 days prior to randomization, whole-brain radiotherapy within 14 days prior to randomization, or neurosurgical resection within 28 days prior to randomization.

The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.

Trial design

Treatments tested in this trial

Atezolizumab 1200 mg
Imatinib 400 MG

Treatment groups

110 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov