MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma (COTESARC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04216953|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma,Soft Tissue||Drug: Cobimetinib Drug: Atezolizumab||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||February 12, 2020|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||February 1, 2024|
Experimental: Atezolizumab + Cobimetinib
Adults: 20mg film coated tablet
i) powder for oral suspension containing 250mg of cobimetinib
ii) for pediatric patients ≥12 years-old and with a BW ≥60kg : 20mg film coated tablet same as adults
Other Name: GDC-0973
20-mL glass vial containing 1200 mg of atezolizumab.
Other Name: RO5541267
- Phase I : Safety Run in [ Time Frame: 28 days ]Incidence of severe toxicities during the first treatment cycle
- Phase II part [ Time Frame: 16 weeks ]The Progression Free rate after 16 weeks of treatment is defined as the rate of patients with a complete response or a partial response or a stable disease as per RECIST V1.1.
- Objective response rate [ Time Frame: at 8 weeks and 16 weeks ]The objective response rate at 8 (16) weeks is defined as the proportion of patients with a complete response or a partial response after 8 (16) weeks of treatment.
- Duration of response [ Time Frame: Time interval from the date of first occurrence of a documented objective response until the date of documented progression or death in the absence of disease progression up to 3 month. ]Duration of response is defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the date of documented progression or death in the absence of disease progression.
- Progression-free survival [ Time Frame: Time from the first day of study treatment to the date of the first documented tumor progression or death up to 3 month. ]Progression-free survival (PFS) is defined as the time from the first day of study treatment to the date of the first documented tumor progression or death due to any cause, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216953
|Contact: Nadège Corradini, MD||+33(0)4 78 78 65 95||Nadege.firstname.lastname@example.org|
|Institut de Cancérologie de l'Ouest||Not yet recruiting|
|Angers, France, 49055|
|Contact: Emmanuelle BOMPAS email@example.com|
|Principal Investigator: Emmanuelle BOMPAS|
|Sub-Investigator: Frédéric ROLLAND|
|Sub-Investigator: Damien VANSTEENE|
|Centre Oscar Lambret||Not yet recruiting|
|Lille, France, 59020|
|Contact: Anne-Sophie DEFACHELLES THOMASSIN +33 (0) 3 20 29 59 59|
|Principal Investigator: Anne-Sophie DEFACHELLES THOMASSIN|
|Sub-Investigator: Sandra RAIMBAULT|
|Sub-Investigator: Hélène SUDOUR-BONNANGE|
|Sub-Investigator: Cyril LERVAT|
|Centre Léon Bérard||Recruiting|
|Lyon, France, 69008|
|Contact: Nadège CORRADINI, MD firstname.lastname@example.org|
|Sub-Investigator: Jean-Yves BLAY|
|Sub-Investigator: Cécile FAURE CONTER|
|Sub-Investigator: Sarah BENEZECH|
|Sub-Investigator: Pierre LEBLOND|
|Sub-Investigator: Perrine MAREC BERARD|
|Sub-Investigator: Medhi BRAHMI|
|Sub-Investigator: Armelle DUFRESNE|
|Sub-Investigator: Isabelle RAY-COQUARD|
|Principal Investigator: Nadège CORRADINI|
|Sub-Investigator: Antony CERAULO|
|Hôpital de la Timone||Not yet recruiting|
|Marseille, France, 13385|
|Contact: Florence DUFFAUD +33 (0)4 91 38 46 44|
|Principal Investigator: Florence DUFFAUD|
|Sub-Investigator: Nicolas ANDRE Nicolas|
|Sub-Investigator: Sébastien SALAS|
|Sub-Investigator: Jean-Claude GENTET|
|Sub-Investigator: Marie MEURER|
|Sub-Investigator: Angélique ROME|
|Sub-Investigator: Arnauld VERSCHUUR|
|Sub-Investigator: Gabriel REVON-RIVIERE|
|Sub-Investigator: Carole COZE|
|Principal Investigator:||Nadège Corradini, MD||Centre Leon Berard|