Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside

NCT06020651 | Completed DMC

• 1 other identifier: CARDIO 05 2022
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date. The VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing:

• surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve) as defined by the International Cardio-Oncology Society;
• circulating biomarkers Before and after receiving ICIs for solid cancer treatment.

Conditions

Renal Cell Carcinoma; Bladder Cancer; MSI-H Cancer; Cancer

Keywords

Atherosclerosis; Cancer; Immune Checkpoint Inhibitor; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Endothelial dysfunction

  Surrogate marker of endothelial dysfunction : Signifiant FMD variation on ICIs as defined by the International Cardio-Oncology Society

  6 weeks

Secondary Outcomes (2)

• Correlation of blood biomarkers to endothelial dysfunction (surrogate marker: Flow Mediated Dilatation variation)

  6 weeks

• Major cardiovascular event (MACE)

  6 months

Study Arms (4)

ICIs alone

EXPERIMENTAL

Participants on ICIs alone

Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement

ICIs + VEGF inhibitors

EXPERIMENTAL

Participants on ICIs + VEGF inhibitors

Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement

ICIs + chemotherapy

EXPERIMENTAL

Participants on ICIs + chemotherapy

Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement

Controls

SHAM COMPARATOR

Participants on other than ICIs cancer therapies

Diagnostic Test: Arterial Doppler for Flow Mediated Reserve measurement

Interventions

Arterial Doppler for Flow Mediated Reserve measurement DIAGNOSTIC_TEST

Arterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs

Also known as: Blood sampling

Controls; ICIs + VEGF inhibitors; ICIs + chemotherapy; ICIs alone

Eligibility Criteria

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

You may qualify if:

• All patients scheduled for first ICI therapy at our institution;
• Matched controls with cancer and no ICI therapy;

You may not qualify if:

• Major cardiovascular event in the past 6 months;
• Unable to provide informed consent;
• History of ICI therapy

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

INstitut Mutualiste Montsouris

Paris, France

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Urinary Bladder Neoplasms; Neoplasms; Atherosclerosis; Vascular Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo the same cardiovascular assessment; only cancer therapies differ according to standard of care.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 31, 2023
• Study Start: June 7, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 1, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)