RecruitingPhase 2NCT05152472

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


Sponsor

Centre Leon Berard

Enrollment

110 participants

Start Date

Jan 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atezolizumab 1200 mg and a drug called Imatinib 400 MG for people with locally advanced gastrointestinal stromal tumor (gist), metastatic gastrointestinal stromal tumor, and other related conditions. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab 1200 mg

(Intravenous administration)

DRUGImatinib 400 MG

(Per os)


Locations(13)

Centre Léon Bérard

Lyon, Rhône, France

Institut Bergonié

Bordeaux, France

Centre Oscar Lambret

Lille, France

Hôpital de La Timone

Marseille, France

Centre Antoine Lacassagne

Nice, France

CHU Poitiers

Poitiers, France

Hôpital Robert Debré

Reims, France

Centre Eugène Marquis

Rennes, France

Institut de cancérologie de l'Ouest

Saint-Herblain, France

Centre Paul Strauss

Strasbourg, France

ICANS CHRU de Strasbourg

Strasbourg, France

Chru Tours

Tours, France

Institut Gustave Roussy

Villejuif, France

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NCT05152472