Actively Recruiting
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
Led by Centre Leon Berard · Updated on 2026-04-24
110
Participants Needed
13
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at consent
- Histologically confirmed diagnosis of GIST
- Locally advanced or metastatic measurable disease by RECIST v1.1
- Prior failure of at least imatinib, sunitinib, and regorafenib treatments
- ECOG Performance Status of 0 or 1
- Adequate bone marrow, coagulation, liver, and renal function per defined lab values
- Ability and willingness to comply with study requirements
- Signed informed consent
- Negative pregnancy test within 72 hours before treatment for women of childbearing potential
- Agreement to use effective contraception during the study
- Medical insurance coverage
You will not qualify if you...
- Prior malignancy within 3 years except locally curable disease without relapse
- Previous imatinib reintroduction after sunitinib as second line
- Known D842V mutation in PDGFRA exon 18
- Prior treatment with CD137 agonists or immune checkpoint inhibitors
- Recent anticancer therapy or investigational treatment within defined washout periods
- Unresolved grade 2 or higher adverse events from prior therapy except alopecia and lab values
- Symptomatic, untreated, or progressing CNS metastases (with specific exceptions for treated asymptomatic lesions)
- Use or need for prohibited concomitant medications, including live vaccines and systemic immunosuppressants
- Active or history of autoimmune or immune deficiency diseases with specific exceptions
- History of severe allergic or hypersensitivity reactions to study drugs
- Active infections including severe infections, hepatitis B or C, tuberculosis, or HIV
- Primary immunodeficiency
- Major surgery within 28 days before treatment or planned during study
- Pregnancy, breastfeeding, or intention to become pregnant during and after treatment
- Impaired ability to swallow or absorb imatinib
- Clinically significant unrelated systemic illness compromising participation
- Patients under tutorship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Centre Léon Bérard
Lyon, Rhône, France, 69373
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
3
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
4
Hôpital de La Timone
Marseille, France, 13385
Actively Recruiting
5
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
6
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
7
Hôpital Robert Debré
Reims, France, 51090
Actively Recruiting
8
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
9
Institut de cancérologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
10
Centre Paul Strauss
Strasbourg, France, 67033
Not Yet Recruiting
11
ICANS CHRU de Strasbourg
Strasbourg, France, 67200
Terminated
12
Chru Tours
Tours, France, 37044
Actively Recruiting
13
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
J
Julien GAUTIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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