RecruitingPhase 2NCT04116541

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.


Sponsor

Centre Leon Berard

Enrollment

455 participants

Start Date

Jan 28, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment. Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion. In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers. All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent. Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor: * Evidence of clinical benefit as assessed by the investigators, * Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease, * No decline in ECOG Performance Status (PS) that can be attributed to disease progression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Alectinib, a drug called Avapritinib, and others for people with malignant solid tumor. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHDM201

HDM201 120mg, Every 3 weeks, Per os

DRUGRibociclib

Ribociclib 200mg/day, once daily 2 weeks on/1 week off, Per os

DRUGCabozantinib

Cabozantinib, 60 mg /day, continuous, Per os

DRUGAlectinib

Alectinib, 600mg twice daily, Per os

DRUGRegorafenib

Regorafenib 160mg, once daily, 3 weeks on/1 week off, Per os

DRUGTrametinib

Trametinib 2 mg/day, continuous, Per os

DRUGDabrafenib

Dabrafenib 150 mg twice daily, Per os

DRUGAvapritinib

300 mg/day,continuous, Per os


Locations(13)

INSTITUT DE CANCEROLOGIE DE L'OUEST Pays de Loire

Angers, France

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Léon Bérard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine LACASSAGNE

Nice, France

Institut Curie

Paris, France

Centre Henri Becquerel

Rouen, France

Centre Paul Strauss

Strasbourg, France

Institut de Cancérologie de Strasbourg

Strasbourg, France

CHU Strasbourg - Hôpital de Hautepierre

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04116541


Related Trials