CompletedNot Applicable

Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)

Spain242 participantsStarted 2019-08-25

Plain-language 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.

Who can participate

Age range16 Years – 99 Years

SexALL

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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.

What they're measuring

Incidence of irAEs.

Timeframe: At 48 weeks from the initiation of ICIs.

Trial details

NCT IDNCT03868046

SponsorHospital Universitario Araba

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-31

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