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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

Study acronym: ATEZOGIST
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 1 of 13 sitesv9
  2. Eligibility criteria shortened, about 26 wordsv8
  3. Study sites: 12 to 13
    • Eligibility criteria shortened, about 30 words
    • Study description expanded, about 27 words
    v7
  4. Study sites: 11 to 12v6
  5. Primary completion date: Jan 2025 to Oct 2027
    • Study completion date: Jun 2026 to Oct 2027
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 5 to 11v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 5
    • Primary completion date: Dec 2025 to Jan 2025
    • Start date changed from estimate of Dec 2021 to Jan 14, 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05152472
Lead Sponsor Centre Leon Berard
Conditions
(from sponsor)		 Unresectable Gastrointestinal Stromal Tumor (GIST), Locally Advanced Gastrointestinal Stromal Tumor (GIST), Metastatic Gastrointestinal Stromal Tumor
Related terms Gastrointestinal Stromal Tumors, Neoplasms
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov