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NotablePrimary completion date: Feb 2017 to Jul 2018
Site contacts updated at 1 of 10 sites
v8
NotablePrimary completion date: Feb 2020 to Feb 2017
Study sites: 8 to 10
Study completion date: Feb 2020 to Nov 2019
Eligibility criteria expanded, about 32 words
v7
Minor2 versionsRe-verified since Apr 4, 2016, no change to tracked fieldsv5-v6
MinorStudy sites: 6 to 8v4
MinorStudy sites: 4 to 6
Eligibility criteria expanded, about 553 words
v3
NotableTrial status: Not Yet Recruiting to Recruiting
Start date: Feb 2014
Site details revised at 4 of 4 sites
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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): \~ 900 patients treated in the induction period and 350 patients randomized in maintenance period.