MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma — COTESARC  

Sarcoma,Soft Tissue Clinical Trial

Official title: A Multicentre, Open-label, Phase I-II Study Evaluating the Combination of a MEK Inhibitor and a PDL1 Inhibitor in Pediatric and Adult Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma.

Status Recruiting

Clinical Trial Summary

The proposed study conducted in adult and pediatric patients aims to evaluate the safety and clinical activity of atezolizumab + cobimetinib in advanced/metastatic soft tissue sarcomas (up to 80 patients).

Clinical Trial Description

The hypothesis of the proposed combination is as follows: cobimetinib via MEK1/2 inhibition could modify the tumor microenvironment and improve the response of T cells against tumor cells. Therefore, the addition of cobimetinib to atezolizumab may improve immune recognition and result in improved anti-tumour activity.

The combination of cobimetinib and atezolizumab showed clinical activity in a Phase I trial in patients with metastatic colorectal cancer (Atezolizumab 840 mg every 2 weeks and Cobimetinib 60 mg/d) with a disease control rate of 31%. Atezolizumab and cobimetinib are currently being tested in pediatrics in the iMatrix clinical trial with no major safety concerns to date.

A molecular screening step is mandatory for all patients enrolled in this trial in order to document MAPK pathway status and Tumor Mutational Burden (TMB) using FoundationOne test (FOne Heme). ;

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma,Soft Tissue

• NCT number: NCT04216953
• Study type: Interventional
• Source: Centre Leon Berard
• Contact: Nadège Corradini, MD
• Phone: +33(0)4 78 78 65 95
• Email: Nadege.corradini@lyon.unicancer.fr
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 12, 2020
• Completion date: February 1, 2027