Etude : BEAT-MESO /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : BEAT-MESO

Nom :

Traitement : Métastatique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 17/06/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase III, multicentrique, randomisée, comparant l’association atézolizumab + bévacizumab + chimiothérapie standard à l’association bévacizumab + chimiothérapie standard en tant que traitement de première ligne du mésothéliome pleural malin avancé

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C38 - Tumeur maligne du coeur, du médiastin et de la plèvre

Spécialité : Tissu mésothélial et tissus mous
Localisation : C45 - Mésothéliome
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.

Malignant pleural mesothelioma (MPM) is a rare and aggressive cancer arising from the mesothelial surface of the pleura. In Europe, the incidence is about 20 per million and is almost always caused by asbestos exposure, with a usual lag time of 30 years between exposure and presentation. Patients diagnosed with advanced MPM have limited treatment options, representing a strict unmet need. Despite decades of clinical research, cytotoxic chemotherapy remains one of the few therapeutic options that has been proven to improve survival in advanced MPM in a randomised controlled trial.

The combination of cisplatin and pemetrexed has become standard first-line therapy worldwide for patients who are not suitable for aggressive surgery or in whom chemotherapy is recommended as part of a multimodality regimen. Carboplatin is often substituted for cisplatin, due to simpler and shorter administration and assumption of a more favourable toxicity profile based on experience in other diseases. Patients with MPM have limited treatment options, representing a strict unmet need.

An antibody is a common type of protein usually made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. The two monoclonal antibodies (atezolizumab and bevacizumab) used in this trial are laboratory-produced antibodies. Atezolizumab is engineered to attach to immune cells to stimulate their activity against cancer cells.

Atezolizumab and bevacizumab are both approved by the European Medicines Agency for the treatment of lung and other cancers. The addition of atezolizumab to bevacizumab plus standard chemotherapy for the treatment of MPM is being investigated in this trial.

All participants will receive 4-6 cycles of standard chemotherapy consisting of carboplatin AUC 5 (area under the plasma concentration versus time curve) plus pemetrexed 500mg/m^2 given intravenously, on day 1 of every 3 week cycle for about 12 to 18 weeks.

Participants will be randomly assigned to one of two treatment groups:
- Treatment 1: Bevacizumab 15 mg/kg intravenously on day 1 of every 3-week cycle, plus 4-6 cycles of chemotherapy
OR
- Treatment 2: Atezolizumab 1200 mg fixed dose intravenously on day 1 of every 3-week cycle, plus Bevacizumab 15 mg/kg, intravenously on day 1 of every 3-week cycle, plus
4-6 cycles of chemotherapy

Participants will continue to receive treatment until disease progression, or until treatment is stopped at the request of the participant or treating doctor, or the participant withdraws consent.

A total of 320 participants from approximately 45 centres in Europe are expected to be included in this trial which will take approximately 6 years to be completed after the first participant is enrolled.

Phase : III

Stade : Localement avancé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically confirmed advanced malignant pleural mesothelioma (all histological subtypes are eligible)
- Not amenable for radical surgery based on local standards
- Evaluable disease or measurable disease as assessed according to the modified response evaluation criteria for solid tumours for mesothelioma (mRECIST) v1.1
- Availability of tumour tissue for translational research
- Age >18 years
- Performance Status 0-1
- Life expectancy >3 months
- Adequate haematological, renal and liver function
- Completed baseline quality of life (QoL) questionnaire
- Women of childbearing potential and sexually active men must agree to use highly effective contraception
- Able to understand and give written informed consent and comply with trial procedures

Critères de non-inclusion : - Prior treatment for malignant pleural mesothelioma
- Treatment with systemic immune-stimulatory agents within 4 weeks or five half-lives of the drug prior to randomisation and during protocol treatment.
- Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation and during protocol treatment.
- Previous allogeneic tissue/solid organ transplant
- Live vaccines within 4 weeks prior to first dose of protocol treatment
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease within 6 months prior to randomisation
- History of haemoptysis
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03762018
Promoteur :
European Organisation for Research and Treatment of Cancer - EORTC
Type de sponsor : Institutionnel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Youssef OULKHOUIR

TEC / ARC / IDE :
Vincent LEON
leon-v@chu-caen.fr

Statut de l'essai : OUVERT

MAJ : 17/06/2020