This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm.
Approximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM.
Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum.
Once the patient discontinues study treatment, the treatment period will end and the patient will enter the follow-up period. No cross-over is allowed between arms.
Signed written Informed Consent.
Subjects must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
Histological diagnosis (no cytology allowed, thoracoscopy biopsy recommended).
ECOG PS>2.
Previous cancer treatment including chemotherapy or immunotherapy with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody.
Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.
Peritoneal, pericardial or tunica vaginalis testis mesothelioma.
Intergroupe Francophone de Cancerologie Thoracique
Lead sponsor
Regeneron Pharmaceuticals
Collaborator