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Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)

NCT03868046 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2025-04-01

No results posted yet for this study

Summary

The aim of this study is to assess the effectiveness of a battery of autoantibodies to predict the occurrence of immune-related adverse events (irAEs) in patients with cancer who will be treated with immune checkpoint inhibitors (ICIs) per standard protocol.

Conditions

Interventions

DRUG

Treatment with immune checkpoint inhibitors.

Treatment with approved immune checkpoint inhibitors, namely ipilimumab, nivolumab, pembrolizumab, atezolizumab and avelumab, alone or in combination, administered per standard protocol.

DIAGNOSTIC_TEST

Blood tests.

Patients will undergo ordinary blood tests obtained at specific moments predefined per protocol and extraordinary blood tests at the time of the detection of an eventual irAE.

Sponsors & Collaborators

  • Hospital de Basurto

    collaborator OTHER

  • Hospital Donostia

    collaborator OTHER

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Hospital Galdakao-Usansolo

    collaborator OTHER_GOV

  • Hospital Universitario Araba

    lead OTHER

Principal Investigators

  • Iñigo Les Bujanda, MD PhD · Hospital Universitario Araba

Eligibility

Min Age
16 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-25
Primary Completion
2023-10-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868046 on ClinicalTrials.gov