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

Lung Cancer Clinical Trial

— IMMUNOVASC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655663
• Other study ID #: CHB19.02
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: December 20, 2025

Study information

• Verified date: December 2022
• Source: Centre Henri Becquerel
• Contact: Doriane Richard, PhD
• Phone: +33232082985
• Email: doriane.richard[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 20, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Vascular investigation
Measure of of carotid stiffness

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increasing of aortic arterial stiffness	Difference of aortic arterial stiffness between 42 days after inclusion and inclusion	42 days
Secondary	Overall survival	Time between death and inclusion	one year