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

Primary Purpose

Head and Neck Cancer, Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vascular investigation
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancer focused on measuring immune checkpoint inhibitor, head and neck cancer, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Henri BecquerelRecruiting
  • CHU RouenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICI

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival
Time between death and inclusion

Full Information

First Posted
December 9, 2022
Last Updated
December 9, 2022
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT05655663
Brief Title
Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer
Acronym
IMMUNOVASC
Official Title
Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab) in Patients Head and Neck or Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Anticipated)
Primary Completion Date
February 10, 2025 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lung Cancer
Keywords
immune checkpoint inhibitor, head and neck cancer, lung cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICI
Arm Type
Experimental
Arm Description
Patients under ICI treatment for their cancer will have vascular investigation and biological assessment
Intervention Type
Other
Intervention Name(s)
Vascular investigation
Intervention Description
Measure of of carotid stiffness
Primary Outcome Measure Information:
Title
Increasing of aortic arterial stiffness
Description
Difference of aortic arterial stiffness between 42 days after inclusion and inclusion
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time between death and inclusion
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Olympios, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Olympios, MD
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Guisier, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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