Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment
Status:
Recruiting
Trial end date:
2026-10-01
Target enrollment:
Participant gender:
Summary
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 receive the matching targeted therapy during 12 weeks (MTT) or 52
weeks (IT). At the end of this induction period:
MTT cohorts :
- patients with a tumor response (CR: complete response or PR: partial response) will
continue the targeted therapy,
- patients in progression will discontinue the targeted therapy and will be withdrawn from
study and oriented towards standard treatments
- patients with a stable disease at 12 weeks will be randomized in order to determine if
they continue or stop the therapy.
IT cohort :
- patients with SD, PR or CR at 52 weeks will be randomized in order to determine if they
continue or stop the therapy.
For each MTT treatment group: ~80 patients treated in the first step (induction period), 50
patients randomized in the second step (maintenance period, 25 patients per arm).
For IT treatment group: ~125 patients treated in the first step (induction period), 50
patients randomized in the second step (maintenance period, 25 patients per arm).
In total (for 7 treatment groups): ~ 600 patients treated in the induction period and 350
patients randomized in maintenance period.