Skip to content

Immune checkpoint inhibition associated cardiovascular adverse events in cancer patients

Immune checkpoint inhibition associated cardiovascular adverse events in cancer patients - ITHACA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51839
Enrollment
214
Registered
2022-09-07
Start date
2023-03-17
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular disease (CVD)

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult male or female, age >=50 years - Prior to start therapy - Confirmed diagnosis of cancer: - Treatment-naive advanced esophageal, gastric, or gastro-esophageal cancer planned for first-line nivolumab or chemotherapy only or follow-up only after resection - Treatment-naive advanced colorectal cancer planned for first-line pembrolizumab or other systemic therapies - Recurrent or metastatic head/neck squamous cell carcinoma with disease progression during platinum-based chemotherapy who are planned for pembrolizumab or other systemic therapies - Non-small-cell lung carcinoma planned for pembrolizumab or durvalumab or other systemic therapies - Advanced renal cell carcinoma planned for first-line ipilimumab/nivolumab or other systemic therapies - Inresectible or advanced melanoma planned for ipilimumab/ nivolumab

Exclusion criteria

Exclusion criteria: • ICI therapy in previous 12 months; • Suspected or confirmed viral, fungal, or bacterial infectious disease; • Use of immunosuppressive therapy prior to ICI start; • Estimated glomerular filtration rate (eGFR)

Design outcomes

Primary

MeasureTime frame
Primary parameter: absolute total coronary plaque volume progression

Secondary

MeasureTime frame
Secundary parameters: - CCTA (coronair): plaque progression and plaque characteristics (vulnerability) - CTA carotid): plaque progression and plaque characteristics (vulnerability) - Clinical outcomes: cardiovacular disease events (i.g. myocardial infarction, stroke), venous thromboembolism, immune related adverse events, death of any cause

Countries

Netherlands

Contacts

Public ContactA Strijdhorst

Amsterdam UMC

a.strijdhorst@amsterdamumc.nl0205665975

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)