Can OSE Immunotherapeutics connect me to the examiners of the study?
OSE Immunotherapeutics is not authorized to answer any request for information about the participation to its clinical trial. Patients must discuss their medical condition and treatment options with their doctors, who will connect them to the examiners of the trial (doctors in charge of the clinical trial sites).
How do you take part to a clinical study?
If you’re willing to take part in a trial, the first thing to do is to talk about it with your oncologist. He/she will then see the main examiner of the trial. The main examiner is a doctor who will decide whether you are able to take part in the trial by meeting all the eligibility criteria.
What does a participation to a clinical study imply?
Every person taking part in a clinical study must sign an informed consent document. It includes information on the study, such as its goal, its duration, the required procedures and contacts.
The informed consent document also details the risks and the potential benefits following their involvement in the study. After signing the informed consent document, the participant will undergo several tests and answer questions about its medical condition to determine if he or she is eligible for the trial.
If the person is eligible for the trial and decides to participate, she will receive a treatment in accordance with the trial protocol and will be followed by the hospital at several defined moments of the study.
Do patients know what treatment is administrated during the trial?
The clinical study of Tedopi® is an “open” study. The doctor and the patient must know which treatment is administered.
Who may participate in a clinical trial?
Every clinical trial is conducted in accordance with a plan, called protocol. The protocol describes the specific criteria that a person must meet to be eligible for the trial (inclusion and exclusion criteria). To be eligible for the trial of Tedopi® on non-small cell lung cancer at an advanced stage, patients must present a positive response to the HLA-A2 marker.
What is a clinical trial?
Clinical trials are studies conducted to better understand human diseases and discover better ways to diagnose, prevent and treat these diseases.
Clinical trials are compulsory, prior to any launch of treatment or medicine. Clinical trials aim to determine whether a new treatment is effective and safe.
Clinical trials are conducted through several phases, with a preset goal:
Phase I: assesses safety (innocuousness) and identifies side effects
Phase II: assesses innocuousness, feasibility and efficiency
Phase III: confirms efficiency, checks side effects, compares the treatment to standard or equivalent treatments
Phase IV : after approval of the medicine by the relevant Health Authorities (Food and Drug Administration in the USA, European Medicines Agency in the European Union) and availability for the general public: tracks safety, looks for more information on risks, advantages and the optimal use of the medicine
Is OSE Immunotherapeutics currently conducting clinical trials?
OSE Immunotherapeutics has obtained the authorization to launch its Phase 3 trial on Tedopi® on non-small cell lung cancer, Atalante 1, at an advanced stage with HLA-A2 receptor. This study has been initiated in January 2016.
On June 23, 2017, OSE Immunotherapeutics announced that following the recommendation by IDMC (independent experts) on the phase 3 clinical study Atalante 1, the Company is temporarily pausing patient accrual while continuing treatment for patients already enrolled in order to further assess the study’s current patient profile in relation to the potential benefit of Tedopi® with more mature data.