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

NCT05655663 | Unknown

• 1 other identifier: CHB19.02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Cancer; Lung Cancer

Keywords

immune checkpoint inhibitor; head and neck cancer; lung cancer

Outcome Measures

Primary Outcomes (1)

• Increasing of aortic arterial stiffness

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

  42 days

Secondary Outcomes (1)

• Overall survival

  one year

Study Arms (1)

ICI

EXPERIMENTAL

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

Other: Vascular investigation

Interventions

Vascular investigation OTHER

Measure of of carotid stiffness

ICI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (2)

Centre Henri Becquerel

Rouen, 76000, France

RECRUITING

CHU Rouen

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nathalie Olympios, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: December 20, 2022
• Primary Completion: February 10, 2025
• Study Completion: December 20, 2025
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)