Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer

Study Overview
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Brief Summary
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Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor. Other approaches exist, such as oncology-specific basket studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer. In addition, trials are underway to investigate the benefit of ICIs in other locations. Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.

Official Title
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Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab) in Patients Head and Neck or Lung Cancer

Conditions
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Head and Neck Cancer, Lung Cancer

Intervention / Treatment
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* Other: Vascular investigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Patient over 18 years of age Patient with lung or head and neck cancer who should be treated with ICI as a single agent according to the market indications, decision taken during a multidisciplinary consultation meeting WHO 0 or 1 Patient affiliated to or benefiting from a social protection scheme. Exclusion Criteria: Indication for combined anti-PD-1 and chemotherapy (for patients with lung cancer) History of radiotherapy treatment History of chemotherapy or targeted therapy within the last 3 weeks Bilateral vascular carotid murmur Absence of sinus rhythm Presence of a pacemaker with permanent electrical stimulation Absence of peripheral carotid and/or femoral pulses on both sides Contraindication to the prescription of an ICI Patient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorship Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICI<br>Patients under ICI treatment for their cancer will have vascular investigation and biological assessment | Other: Vascular investigation<br>* Measure of of carotid stiffness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increasing of aortic arterial stiffness | Difference of aortic arterial stiffness between 42 days after inclusion and inclusion | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time between death and inclusion | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune checkpoint inhibitor, head and neck cancer, lung cancer