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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Lung Cancer
• Intervention / Treatment: Other: Vascular investigation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Nathalie Olympios, MD
  • Rouen, France, 76000
    • Recruiting
    • CHU Rouen
    • Contact: Florian Guisier, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Nathalie Olympios, MD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): February 10, 2025
• Study Completion (Anticipated): December 20, 2025

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; head and neck cancer; immune checkpoint inhibitor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CHB19.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No