Condition: Malignant Solid Neoplasms · Sponsor: Centre Leon Berard
The MOST Plus study is a two-period phase II clinical trial, conducted in patients with all types of progressive solid tumors after at least 1 prior systemic treatment regimen for advanced disease (in the absence of a validated second line therapy). The main goal of this study is to evaluate for these patients the clinical benefit of a maintenance treatment in patients with stable disease (SD) after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or with SD, partial response (PR) or complete reponse (CR) with Immunotherapy (IT)). For MTT, the first period of this trial (induction period) will enable to establish whether the identification of genomic alterations in genes encoding for "actionable" targets in the tumor cells, regardless of the histological subtype, can be used to select efficient treatment targeting the pathway activated by the mutation. For Immunotherapy, induction period with durvalumab + tremelimumab is expected to be an innovative therapy for an efficient tumor control and may allow to identify types of cancer or molecular types of cancer that are more receptive to immunotherapy. For all treatments, the second period (maintenance period) will use a randomized design to evaluate the clinical benefit of a maintenance treatment with the targeted therapy or immunotherapy selected based on tumor molecular profile in patients treated by MTT with SD and in patients treated by IT with SD, PR or CR. Each patient enrolled will receiv…
This description comes directly from the study's public registry record.
Jean-Yves BLAY, MD · +33478785126 · jean-yves.blay@lyon.unicancer.fr
Olivier TREDAN, MD · +33478782828 · olivier.tredan@lyon.unicancer.fr
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| Institut Bergonié | Bordeaux, France | Recruiting |
| Centre Leon Berard | Lyon, France | Recruiting |
| Centre Hospitalier Lyon Sud | Lyon, France | Recruiting |
| Institut Paoli Calmettes | Marseille, France | Recruiting |
| Institut Curie | Paris, France | Recruiting |
| Institut de Cancerologie de Strasbourg Europe | Strasbourg, France | Recruiting |
| Institut Claudius Regaud | Toulouse, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT02029001