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Completed

NCT Number: NCT03868046

Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)

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.

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Key information

Conditions

Cancer Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Solid Organ Cancer

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, 01009, Spain

About this study

Introduction: Treatment with ICIs is leading to a remarkable improvement in the prognosis of several types of cancer. However, the expansion of these drugs in the field of oncology is also causing the emergence of a large diversity of irAEs, whose optimal prevention and management are still to be clarified. Nowadays, there is a growing need for reliable and validated biomarkers to predict the occurrence of irAEs in patients treated with ICIs.

Purpose: To assess the effectiveness of a battery of autoantibodies available in a laboratory of autoimmunity to predict the occurrence of irAEs in patients with cancer who will be treated with ICIs per standard protocol.

Methods: A multicenter prospective observational cohort study was designed to include a total of 221 patients diagnosed with cancer amenable to treatment with ICIs. During a period of 48 weeks, patients will be controlled in the oncology outpatient clinics of five university hospitals with accredited experience in the management of immunotherapy. Immune-related adverse events will be defined and categorized according to CTCAE v. 5.0. Considering a proportion of irAEs and losses to follow-up of 25% and 5% respectively, a sample size of 221 patients was calculated to estimate an expected sensitivity of the autoantibody battery of 0.90 with a 95% confidence interval not lower than 0.75. All the participants will undergo ordinary blood tests at specific moments predefined per protocol and extraordinary blood tests at the time of the detection of an eventual irAE. Both ordinary and extraordinary samples will be frozen and stored in the biobank of each participating hospital in the form of serum and buffy coat. Once the whole cohort reaches the 24th week (intermediate analysis) and the 48th week (definitive analysis), all the samples will be centralized in the same autoimmunity laboratory for the determination of the autoantibody battery. A predictive model of irAEs will be constructed with the autoantibodies together with other potential risk factors of immune-mediated toxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Initiation of treatment with a single ICI or a combination of ICIs.
  • Acceptation of an informed consent.

Exclusion criteria

  • Life expectancy lower than 3 months from the initiation of treatment with ICIs.
  • Proven hypersensitivity or previous allergic anaphylactic reaction induced by a specific ICI.
  • Active autoimmune disease with severe involvement.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3.
  • Ongoing immunosuppressive therapy: prednisone at doses >10 mg/day or equivalent (>1.5 mg/day of dexamethasone), and/or any dose of azathioprine, methotrexate, mycophenolate, cyclophosphamide, leflunomide, rituximab, anti-tumor necrosis factor drugs (infliximab, etanercept, adalimumab, golimumab), belimumab and abatacept.

Treatment and study plan

Treatment with immune checkpoint inhibitors.

Drug

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

Blood tests.

Diagnostic Test

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.

Primary outcomes

  1. Incidence of irAEs.

    Time frame: At 48 weeks from the initiation of ICIs.

    An irAE was defined as any symptom, sign, syndrome or disease attributable to an immune activation mechanism during an ongoing treatment with an ICI or a combination of ICIs, provided that an infectious cause and/or tumor progression have been ruled out.

Secondary outcomes

  1. irAE-free survival.

    Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.

    Time in months from the initiation of therapy with ICIs until the occurrence of an irAE or until the date of the last follow-up.

  2. Progression-free survival.

    Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.

    Time in months from the initiation of therapy with ICIs until the date of proven tumor progression or until the date of the last follow-up.

  3. Overall survival.

    Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.

    Time in months from the initiation of therapy with ICIs until the date of patient's death or until the date of the last follow-up.

  4. Incidence of development of autoantibodies.

    Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.

    Positive conversion of the autoantibody battery after the initiation of therapy with ICIs.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Araba

Other

Collaborators

  • Complejo Hospitalario de Navarra
  • Hospital Donostia
  • Hospital Galdakao-Usansolo
  • Hospital de Basurto

Registry information

Official study title

Prediction of Immune-related Adverse Events Induced by Anti-CTLA4 and Anti-PD1/PDL1 Drugs by Means of a Battery of Autoantibodies. a Multicenter Prospective Observational Cohort Study

Acronym: AUTENTIC

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2019
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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