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Article History

Received: 27 November 2019

Accepted: 7 April 2020

First Online: 25 April 2020

Ethics approval and consent to participate

: This trial is carried out in accordance with Public Health Act 2004–806 of 9 August 2004 concerning biomedical research, Decree No. 2006–477 of 26.04.04, 2006 amending Chapter I of Title II of Book 1 of the first part of the Public Health Code concerning biomedical research and the decrees in force. The Investigator and the promoter undertake to follow the rules of good clinical practice (BPC) of biomedical research on medicinal products for human use, mentioned in Article L. 1121–3 of the Public Health Code and Order of 23 April 2004. The current study is conducted in accordance with globally accepted standards of Good Clinical Practice (ICH-E6), European Directive 2001/20/EC, and the revised version of the Declaration of Helsinki set out in the European Directive, as well as with the Certificate Service Providers (CSP) specific to France. Before the study start, each patient is informed by the Investigator, in writing as well as verbally, about the nature and implications of the proposed study, and chiefly of the possible benefits and risks for their health, having this notice been previously approved by the Committee for the Protection of Persons. Patients have at least 48 h for reflexion on the topic. Consequently, patients document their approval by signing an informed consent form before any intervention or procedure specified in the protocol. Both, the Investigator and the patient, sign the consent form, and each part saves one example. The study was approved by the independent Committee for Protection of Persons “Sub Méditerranée IV” (April 10, 2018) and by the French Health Products Safety Agency (April 16, 2018).For biomedical research in France: The Sponsor attests his conformity regarding the Personal Data Protection French requirements with the current version of “Méthodologie de Réference MR001”.In accordance with the law “Informatique et Libertés” (Law 78–17 of 6 January 1978 amended by Act 2004–801 of 6 August 2004), the type of data collected concerning patients participating in this study will be sent to the Data Protection Supervisory Authority (CNIL). Patients will be informed of this procedure and of their right of access and rectification of the data concerning them.A processing of the personal data will be implemented to allow analysis of the results, under conditions ensuring their confidentiality. These data may, under conditions guaranteeing their confidentiality, be transmitted to the French or foreign health authorities. The patient has a right of access and rectification. The patient also has the right to object to the transmission of his/her personal data used in this study. These rights are exercised with the investigating physician who follows the patient in the course of the study and who knows the patient identity.Approval by the Méditerranée-4 Committee for Protection of Persons on May 15, 2018 and by the French Health Products Safety Agency on April 16, 2018.<b>Protocol version:</b> 2.0, February 5th 2019.

: Not applicable.

: Genentech provides atezolizumab and Roche France funds the study.The authors declare no other competing interests.