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
Study ID
NCT05152472
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Gastrointestinal Stromal Tumor (GIST)
  • Metastatic Gastrointestinal Stromal Tumor
  • Unresectable Gastrointestinal Stromal Tumor (GIST)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 14, 2022
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Imatinib + Atezolizumab
    Imatinib per os 400 mg daily continuously associated with intravenous administrations of atezolizumab at the fixed dose of 1 200 mg every 3 weeks (up to 12 months)
  • Active Comparator: Imatinib alone
    Imatinib alone, per os 400 mg daily continuously (up to 12 months)

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 48 months ]

Central Contacts