CClinicalTrials.gg
RecruitingNCT05655663IMMUNOVASCUpdated Dec 19, 2022

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

An interventional study of Vascular investigation in Head and Neck Cancer and Lung Cancer, sponsored by Centre Henri Becquerel. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer
  • Lung Cancer

Keywords

  • immune checkpoint inhibitor
  • head and neck cancer
  • lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    ICI

    Patients under ICI treatment for their cancer will have vascular investigation and biological assessment

    Other: Vascular investigation

Interventions

  • OtherVascular investigation

    Measure of of carotid stiffness

06

What researchers measure

Primary outcomes

  1. Increasing of aortic arterial stiffness

    Difference of aortic arterial stiffness between 42 days after inclusion and inclusion

    Time frame: 42 days

Secondary outcomes

  1. Overall survival

    Time between death and inclusion

    Time frame: one year

07

Study locations

2 of 2 sites recruiting
  • Centre Henri Becquerel
    Rouen, 76000, France
    • Nathalie Olympios, MD · Contact
    Recruiting
  • CHU Rouen
    Rouen, 76000, France
    • Florian Guisier, MD, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05655663
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
Dec 19, 2022
Start date
Dec 20, 2022 (estimated)
Primary completion
Feb 10, 2025 (estimated)
Completion
Dec 20, 2025 (estimated)
Last update
Dec 19, 2022

Study contacts

Doriane Richard, PhD
Contact
doriane.richard@chb.unicancer.fr
+33232082985
Nathalie Olympios, MD
principal investigator · Centre Henri Becquerel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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