OncoMatch/Clinical Trials/NCT05152472
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
Is NCT05152472 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab 1200 mg and Imatinib 400 MG for unresectable gastrointestinal stromal tumor (gist).
Treatment: Atezolizumab 1200 mg · Imatinib 400 MG — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Excluded: PDGFRA D842V
Known D842V mutation in Exon 18 of PDGFRA [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: tyrosine kinase inhibitor (imatinib, sunitinib, regorafenib)
Patients who previously failed to at least imatinib, sunitinib and then regorafenib. Failure is defined for Imatinib as progressive disease, and for sunitinib and regorafenib as progressive disease and/or intolerance
Cannot have received: tyrosine kinase inhibitor (imatinib)
Exception: already reintroduced after sunitinib as second line
Patients in whom imatinib had been already reintroduced after sunitinib as second line
Cannot have received: immune checkpoint inhibitor
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4 , anti-TIGIT, anti PD-1,and anti PD-L1 therapeutic antibodies
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dl; ANC ≥ 1.5 G/l; Lymphocytes ≥ 0.5 G/l; Platelets ≥ 100 G/l
Kidney function
Serum creatinine ≤ 1.5 x ULN or Cr. Cl. ≥ 40ml/min/1.73m² (MDRD or CKD-EPI formula)
Liver function
Total serum bilirubin ≤ 1.5 x ULN (except Gilbert's syndrome ≤ 3.0 x ULN); Transaminases (ASAT/ALAT) ≤ 2.5 x ULN (or ≤ 5.0 x ULN with liver metastases); Alkaline Phosphatases ≤ 2.5 x ULN (or ≤ 5.0 x ULN with bone metastases)
Adequate bone marrow and organ function defined by the following laboratory results: ... (see full text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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