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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

ConditionsUnresectable Gastrointestinal Stromal Tumor (GIST)Locally Advanced Gastrointestinal Stromal Tumor (GIST)Metastatic Gastrointestinal Stromal Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Measurable disease, per RECIST v1.1, must be present outside the CNS.

The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.

The patient has not undergone stereotactic radiotherapy within 7 days prior to randomization, whole-brain radiotherapy within 14 days prior to randomization, or neurosurgical resection within 28 days prior to randomization.

The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atezolizumab 1200 mg

    Drug

    (Intravenous administration)

  • Imatinib 400 MG

    Drug

    (Per os)

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Imatinib + AtezolizumabExperimental treatment 2 interventions
Group B: Imatinib aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time from the date of randomization to the date of first disease progression, or death from any cause, whichever occurs first

Time frame
48 months

Secondary outcomes

1

Best Response Rate (BRR)

The best response from randomization : Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)

Time frame
48 months
2

Objective Response Rate (ORR)

The proportion of patients with a best overall response of CR or PR during the study

Time frame
48 months
3

Time to Treatment Failure (TTF)

The time from the date of randomization to the date of permanent study treatments discontinuation (any cause, including death, progression, discontinuation of treatment due to progression, toxicity or start of a new anticancer therapy and withdrawal of consent)

Time frame
48 months
4

Overall Survival (OS)

The time from the date of randomization to the date of death due to any cause

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov
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