Evaluating the vascular effects of immune checkpoint inhibitors in lung and head and neck cancer patients
Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab) in Patients Head and Neck or Lung Cancer
This study is testing whether immune checkpoint inhibitors can help people with lung or head and neck cancer while also looking at any potential problems with their blood vessels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Henri Becquerel Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Rouen and 1 other locations) |
| Trial ID | NCT05655663 on ClinicalTrials.gov |
What this trial studies
This study investigates the vascular toxicity associated with immune checkpoint inhibitors (ICIs) in patients diagnosed with head and neck or lung cancer. It aims to identify patient profiles that may benefit from ICIs while assessing potential vascular complications. Eligible participants are those who are over 18 years old and have been recommended for ICI treatment following a multidisciplinary consultation. The study excludes patients with certain medical histories or conditions that may interfere with the treatment or assessment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with lung or head and neck cancer who are eligible for ICI treatment as a single agent.
Not a fit: Patients who have contraindications to ICIs or those with recent chemotherapy or targeted therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of vascular risks associated with ICIs, leading to safer treatment protocols for patients.
How similar studies have performed: While there have been numerous studies on ICIs, this specific focus on vascular toxicity is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rouen and 1 other locations
- Centre Henri Becquerel — Rouen, France (Recruiting)
- CHU Rouen — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Nathalie Olympios, MD — Centre Henri Becquerel
- Study coordinator: Doriane Richard, PhD
- Email: doriane.richard@chb.unicancer.fr
- Phone: +33232082985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.