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Clinical Trials/NCT05655663
NCT05655663
Recruiting
Not Applicable

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

Centre Henri Becquerel2 sites in 1 country30 target enrollmentDecember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Centre Henri Becquerel
Enrollment
30
Locations
2
Primary Endpoint
Increasing of aortic arterial stiffness
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2022
End Date
December 20, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Increasing of aortic arterial stiffness

Time Frame: 42 days

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

Secondary Outcomes

  • Overall survival(one year)

Study Sites (2)

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