Last updated on July 2019

Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: My Own Specific Treatment

Brief description of study

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 after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or 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 this targeted therapy selected based on tumor molecular profile in patients with stable disease.

Each patient enrolled will receive the matching targeted therapy during 12 weeks (MTT) or 24 weeks (IT). At the end of this induction period:

  • patients with a tumor 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  • patients in progression will discontinue the targeted therapy and will be withdrawn from study and oriented towards standard treatments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 (MTT) or 24 weeks (IT) will be randomized in order to determine if they continue or stop the therapy.

About 80 patients will be treated in each of the 5 MTT treatment groups opened to enrollment and 125 patients will be treated in IT treatment groups , each group corresponding to an available targeted therapy.

Clinical Study Identifier: NCT02029001

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