Clinical trial NCT05655663: Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer
Official title: Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab) in Patients Head and Neck or Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lung Cancer
Keywords: immune checkpoint inhibitor
head and neck cancer
lung cancer
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Increasing of aortic arterial stiffness
timeFrame: 42 days
Secondary outcomes:
measure: Overall survival
timeFrame: one year
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: Centre Henri Becquerel
name: Nathalie Olympios, MD
role: PRINCIPAL_INVESTIGATOR
References: