Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05655663
Acronym
IMMUNOVASC
Enrollment
30
Registered
2022-12-19
Start date
2022-12-20
Completion date
2025-12-20
Last updated
2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Lung Cancer

Keywords

immune checkpoint inhibitor, head and neck cancer, lung cancer

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.

Interventions

OTHERVascular investigation

Measure of of carotid stiffness

Sponsors

Centre Henri Becquerel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Increasing of aortic arterial stiffness42 daysDifference of aortic arterial stiffness between 42 days after inclusion and inclusion

Secondary

MeasureTime frameDescription
Overall survivalone yearTime between death and inclusion

Countries

France

Contacts

Primary ContactDoriane Richard, PhD
doriane.richard@chb.unicancer.fr+33232082985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026