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Immune-Related Adverse EventsINTER-AUTENTICNCT07249060

Interferon Signature in Anti-CTLA-4 and Anti-PD-1/PD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients

An observational study of Immune-Related Adverse Events and Lupus Erythematosus, Systemic, run by Hospital Universitario Araba at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Immune Checkpoint Inhibitors
How many people
300 participants
Where
1 siteSpain
Study dates
8 Jan 2024to Dec 2026
How long will I take part?
48 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ICI cohort: Patients in the ICI cohort will be recruited from the Medical Oncology outpatient clinics of the participating hospitals. All patients diagnosed with a solid neoplasm eligible for treatment with ICIs will be considered for inclusion, using consecutive case sampling. SAD cohort: Patients in the SAD cohort will be recruited in the outpatient clinics of the HUN Internal Medicine Service's SAD Unit, using consecutive case sampling.

Who may be able to join

  • Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;
  • Patients who are treatment-naïve to ICIs; and
  • Age ≥18 years.
  • Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR/EULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR/EULAR 2016), Systemic Sclerosis (SSc) (ACR/EULAR 2013), and/or Idiopathic Inflammatory Myopathy (IIM) (ACR/EULAR 2017).
  • Age ≥18 years old.

Who cannot join

  • Estimated mortality of less than 3 months from the start of treatment;
  • Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;
  • Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group [ECOG] ≥3);
  • Ongoing immunosuppressive therapy, including prednisone at doses >10 mg/day or equivalent.
  • SAD cohort:
  • Estimated mortality less than 3 months from the start of follow-up.
  • Active immunosuppressive treatment, including prednisone at doses >10 mg/day or equivalent.
  • Recent diagnosis (<1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site, 1 recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Iñigo Les, MD, PhD, 0034848429698, inigo.les.bujanda@navarra.es

    Recruiting

Other trials in Spain

About this study

Official title: Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1/PD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases

This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. At present, clinicians lack reliable tests to determine who is most likely to develop these reactions. The goal of this study is to determine whether substances in the blood called interferons (IFNs) could serve as early warning markers.

The study will include 300 people with cancer who are about to begin immunotherapy. To provide a meaningful comparison, the investigators will also enroll 40 individuals with autoimmune diseases such as lupus. Understanding how IFN levels differ between these groups may help clarify whether IFN patterns in cancer patients resemble those seen in autoimmune disease.

Read more

Participants in both groups will be asked to provide small blood samples at predefined time points during their clinical care or treatment. Researchers will measure the levels of different IFN types in all samples to compare IFN levels between cancer patients and individuals with autoimmune diseases, and within the cancer group between patients who develop irAEs and those who do not. The long-term aim of the study is to develop a simple test that can help clinicians identify patients at higher risk of irAEs.

Immune-related adverse events (irAEs) are a frequent complication in cancer patients treated with immune checkpoint inhibitors (ICIs), and they often resemble or exacerbate preexisting autoimmune diseases. Despite extensive research in the field, no validated predictive biomarkers of irAEs currently exist. Emerging evidence suggests that the IFN signature -long implicated in the pathogenesis of several systemic autoimmune diseases (SADs)- may also be upregulated in patients who develop ICI-induced irAEs, likely with substantial overlap among different IFN subtypes. Given these clinical and molecular similarities with SADs, it is plausible that IFN levels in peripheral blood carry predictive value for irAE risk, although the dominant IFN types in ICI-related toxicity remain unknown.

The INTER-AUTENTIC project aims to determine whether baseline IFN levels and their dynamic changes, measured in peripheral blood using a dedicated panel, can predict the onset of irAEs in cancer patients receiving ICIs. Supported by the Medical Oncology departments of six university hospitals in Northern Spain, this multicenter, observational, prospective cohort study has been underway since 2021. Biobank samples have been collected from ICI-treated patients before treatment initiation, at protocol-defined time points, and at the moment of irAE diagnosis (ICI cohort). The study seeks to identify the IFN subtypes with the most pronounced differential expression between patients with and without irAEs, and to evaluate whether IFN levels enhance the predictive performance of a model incorporating other clinical variables potentially associated with immune-mediated toxicity. A sample size of 300 cancer patients has been estimated for this analysis.

In addition, a second prospective cohort of 40 non-cancer patients with systemic lupus erythematosus, primary Sjögren's syndrome, systemic sclerosis, and/or idiopathic inflammatory myopathy (SAD cohort) will be included. Since IFNs play a well-established pathogenic role in these conditions, this cohort will allow characterization of the IFN signature at key follow-up points (baseline, remission, and disease flare) and comparison with the IFN profiles of ICI-treated patients, regardless of whether they develop irAEs.

Being tested
Immune Checkpoint Inhibitors
Keywords
Immune Checkpoint Inhibitors, Adverse events, Biomarkers, Predictive, Prospective Studies, Immune System
Medical subject headings
Lupus Erythematosus, Systemic, Sjogren's Syndrome, Scleroderma, Systemic, Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immune Checkpoint InhibitorsDrug

    Administration of immune checkpoint inhibitors according to protocol

Study groups in NCT07249060
Study groupRoleWhat they receive
ICI cohortPatients with cancer treated with immune checkpoint inhibitors
Receives: Drug: Immune Checkpoint Inhibitors
SAD cohortPatients without cancer affected by systemic lupus erythematosus, primary Sjögren's syndrome, progressive systemic sclerosis, and/or idiopathic inflammatory myopathy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of immune-related adverse event

    any symptom, sign, syndrome, or disease caused by an immune-activating mechanism during the administration of an ICI once other causes such as an infectious disease or tumor progression have been ruled out.

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start8 Jan 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
48 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249060
Sponsor's protocol ID
PI_2023/90
Acronym
INTER-AUTENTIC
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Les I, Perez-Francisco I, Cabero M, Sanchez C, Hidalgo M, Teijeira L, Arrazubi V, Dominguez S, Anaut P, Eguiluz S, Elejalde I, Herrera A, Martinez M. Prediction of Immune-Related Adverse Events Induced by Immune Checkpoint Inhibitors With a Panel of Autoantibodies: Protocol of a Multicenter, Prospective, Observational Cohort Study. Front Pharmacol. 2022 Jun 1;13:894550. doi: 10.3389/fphar.2022.894550. eCollection 2022.

    PubMed 35721217

  • Riudavets M, Mosquera J, Garcia-Campelo R, Serra J, Anguera G, Gallardo P, Sullivan I, Barba A, Del Carpio L, Barnadas A, Gich I, Majem M. Immune-Related Adverse Events and Corticosteroid Use for Cancer-Related Symptoms Are Associated With Efficacy in Patients With Non-small Cell Lung Cancer Receiving Anti-PD-(L)1 Blockade Agents. Front Oncol. 2020 Sep 7;10:1677. doi: 10.3389/fonc.2020.01677. eCollection 2020.

    PubMed 33014837

  • Hailemichael Y, Johnson DH, Abdel-Wahab N, Foo WC, Bentebibel SE, Daher M, Haymaker C, Wani K, Saberian C, Ogata D, Kim ST, Nurieva R, Lazar AJ, Abu-Sbeih H, Fa'ak F, Mathew A, Wang Y, Falohun A, Trinh V, Zobniw C, Spillson C, Burks JK, Awiwi M, Elsayes K, Soto LS, Melendez BD, Davies MA, Wargo J, Curry J, Yee C, Lizee G, Singh S, Sharma P, Allison JP, Hwu P, Ekmekcioglu S, Diab A. Interleukin-6 blockade abrogates immunotherapy toxicity and promotes tumor immunity. Cancer Cell. 2022 May 9;40(5):509-523.e6. doi: 10.1016/j.ccell.2022.04.004. Epub 2022 May 9.

    PubMed 35537412

  • Bishu S, Melia J, Sharfman W, Lao CD, Fecher LA, Higgins PDR. Efficacy and Outcome of Tofacitinib in Immune checkpoint Inhibitor Colitis. Gastroenterology. 2021 Feb;160(3):932-934.e3. doi: 10.1053/j.gastro.2020.10.029. Epub 2020 Oct 21. No abstract available.

    PubMed 33096100

  • Fernandez-Ruiz R, Niewold TB. Type I Interferons in Autoimmunity. J Invest Dermatol. 2022 Mar;142(3 Pt B):793-803. doi: 10.1016/j.jid.2021.11.031. Epub 2022 Jan 10.

    PubMed 35016780

  • Unger JM, Vaidya R, Albain KS, LeBlanc M, Minasian LM, Gotay CC, Henry NL, Fisch MJ, Lee SM, Blanke CD, Hershman DL. Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials. J Clin Oncol. 2022 May 1;40(13):1474-1486. doi: 10.1200/JCO.21.02377. Epub 2022 Feb 4.

    PubMed 35119908

  • Wang M, Zhai X, Li J, Guan J, Xu S, Li Y, Zhu H. The Role of Cytokines in Predicting the Response and Adverse Events Related to Immune Checkpoint Inhibitors. Front Immunol. 2021 Jul 22;12:670391. doi: 10.3389/fimmu.2021.670391. eCollection 2021.

    PubMed 34367136

  • Traves PG, Murray B, Campigotto F, Galien R, Meng A, Di Paolo JA. JAK selectivity and the implications for clinical inhibition of pharmacodynamic cytokine signalling by filgotinib, upadacitinib, tofacitinib and baricitinib. Ann Rheum Dis. 2021 Jul;80(7):865-875. doi: 10.1136/annrheumdis-2020-219012. Epub 2021 Mar 19.

    PubMed 33741556

  • Coukos A, Vionnet J, Obeid M, Bouchaab H, Peters S, Latifyan S, Wicky A, Michielin O, Chtioui H, Moradpour D, Fasquelle F, Sempoux C, Fraga M. Systematic comparison with autoimmune liver disease identifies specific histological features of immune checkpoint inhibitor-related adverse events. J Immunother Cancer. 2022 Oct;10(10):e005635. doi: 10.1136/jitc-2022-005635.

    PubMed 36283734

  • Pinal-Fernandez I, Quintana A, Milisenda JC, Casal-Dominguez M, Munoz-Braceras S, Derfoul A, Torres-Ruiz J, Pak K, Dell'Orso S, Naz F, Gutierrez-Cruz G, Milone M, Shelly S, Duque-Jaimez Y, Tobias-Baraja E, Matas-Garcia A, Garrabou G, Padrosa J, Ros J, Trallero-Araguas E, Walitt B, Christopher-Stine L, Lloyd TE, Zhao C, Swift S, Rajan A, Grau-Junyent JM, Selva-O'Callaghan A, Liewluck T, Mammen AL. Transcriptomic profiling reveals distinct subsets of immune checkpoint inhibitor induced myositis. Ann Rheum Dis. 2023 Jun;82(6):829-836. doi: 10.1136/ard-2022-223792. Epub 2023 Feb 17.

    PubMed 36801811

  • Salem JE, Bretagne M, Abbar B, Leonard-Louis S, Ederhy S, Redheuil A, Boussouar S, Nguyen LS, Procureur A, Stein F, Fenioux C, Devos P, Gougis P, Dres M, Demoule A, Psimaras D, Lenglet T, Maisonobe T, De Chambrun MP, Hekimian G, Straus C, Gonzalez-Bermejo J, Klatzmann D, Rigolet A, Guillaume-Jugnot P, Champtiaux N, Benveniste O, Weiss N, Saheb S, Rouvier P, Plu I, Gandjbakhch E, Kerneis M, Hammoudi N, Zahr N, Llontop C, Morelot-Panzini C, Lehmann L, Qin J, Moslehi JJ, Rosenzwajg M, Similowski T, Allenbach Y. Abatacept/Ruxolitinib and Screening for Concomitant Respiratory Muscle Failure to Mitigate Fatality of Immune-Checkpoint Inhibitor Myocarditis. Cancer Discov. 2023 May 4;13(5):1100-1115. doi: 10.1158/2159-8290.CD-22-1180.

    PubMed 36815259

  • Soret P, Le Dantec C, Desvaux E, Foulquier N, Chassagnol B, Hubert S, Jamin C, Barturen G, Desachy G, Devauchelle-Pensec V, Boudjeniba C, Cornec D, Saraux A, Jousse-Joulin S, Barbarroja N, Rodriguez-Pinto I, De Langhe E, Beretta L, Chizzolini C, Kovacs L, Witte T; PRECISESADS Clinical Consortium; PRECISESADS Flow Cytometry Consortium; Bettacchioli E, Buttgereit A, Makowska Z, Lesche R, Borghi MO, Martin J, Courtade-Gaiani S, Xuereb L, Guedj M, Moingeon P, Alarcon-Riquelme ME, Laigle L, Pers JO. A new molecular classification to drive precision treatment strategies in primary Sjogren's syndrome. Nat Commun. 2021 Jun 10;12(1):3523. doi: 10.1038/s41467-021-23472-7.

    PubMed 34112769

  • Henderson Berg MH, Del Rincon SV, Miller WH. Potential therapies for immune-related adverse events associated with immune checkpoint inhibition: from monoclonal antibodies to kinase inhibition. J Immunother Cancer. 2022 Jan;10(1):e003551. doi: 10.1136/jitc-2021-003551.

    PubMed 35086945

  • Nunez NG, Berner F, Friebel E, Unger S, Wyss N, Gomez JM, Purde MT, Niederer R, Porsch M, Lichtensteiger C, Kramer R, Erdmann M, Schmitt C, Heinzerling L, Abdou MT, Karbach J, Schadendorf D, Zimmer L, Ugurel S, Klumper N, Holzel M, Power L, Kreutmair S, Capone M, Madonna G, Cevhertas L, Heider A, Amaral T, Hasan Ali O, Bomze D, Dimitriou F, Diem S, Ascierto PA, Dummer R, Jager E, Driessen C, Levesque MP, van de Veen W, Joerger M, Fruh M, Becher B, Flatz L. Immune signatures predict development of autoimmune toxicity in patients with cancer treated with immune checkpoint inhibitors. Med. 2023 Feb 10;4(2):113-129.e7. doi: 10.1016/j.medj.2022.12.007. Epub 2023 Jan 23.

    PubMed 36693381

  • Les I, Martinez M, Perez-Francisco I, Cabero M, Teijeira L, Arrazubi V, Torrego N, Campillo-Calatayud A, Elejalde I, Kochan G, Escors D. Predictive Biomarkers for Checkpoint Inhibitor Immune-Related Adverse Events. Cancers (Basel). 2023 Mar 6;15(5):1629. doi: 10.3390/cancers15051629.

    PubMed 36900420

Questions about this trial

What is this clinical trial studying?

An observational study of Immune-Related Adverse Events and Lupus Erythematosus, Systemic, run by Hospital Universitario Araba at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of immune-related adverse event (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249060, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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