CancerAUTENTICNCT03868046
Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)
An observational study of Cancer and Metastatic Cancer, run by Hospital Universitario Araba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Cancer, Metastatic Cancer, Solid Organ Cancer
- What is being tested?
- Treatment with immune checkpoint inhibitors. and Blood tests.
- How many people
- 242 participants
- Where
- 1 siteSpain
- Study dates
- 25 Aug 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed with cancer amenable to treatment with ICIs will be considered eligible. Potential candidates will be identified and consecutively included in the oncology outpatient clinics of five university hospitals in Spain.
Who may be able to join
- Initiation of treatment with a single ICI or a combination of ICIs.
- Acceptation of an informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Cancer, Metastatic Cancer, Solid Organ Cancer
- Being tested
- Treatment with immune checkpoint inhibitors., Blood tests.
- Keywords
- Immune-related Adverse Events, Immune Checkpoint Inhibitors, Biomarkers, Autoantibodies
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with ICIs. | All enrolled patients must have been diagnosed with a cancer potentially treatable with ipilimumab, nivolumab, pembrolizumab, atezolizumab or avelumab, alone or in combination, per standard protocol. Receives: Drug: Treatment with immune checkpoint inhibitors.; Diagnostic Test: Blood tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of irAEs.
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.
Measured: At 48 weeks from the initiation of ICIs.
Secondary outcomes (4)
irAE-free survival.
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.
Measured: At 24 weeks and at 48 weeks from the initiation of ICIs.
Progression-free survival.
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.
Measured: At 24 weeks and at 48 weeks from the initiation of ICIs.
Overall survival.
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.
Measured: At 24 weeks and at 48 weeks from the initiation of ICIs.
Incidence of development of autoantibodies.
Positive conversion of the autoantibody battery after the initiation of therapy with ICIs.
Measured: At 24 weeks and at 48 weeks from the initiation of ICIs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start25 Aug 2019
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Araba
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Basurto, Hospital Donostia, Complejo Hospitalario de Navarra, Hospital Galdakao-Usansolo
- Responsible party
- Principal investigator, Iñigo Les Bujanda, Hospital Universitario Araba
- Investigators
- Iñigo Les Bujanda, MD PhD, Principal investigator, Hospital Universitario Araba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868046
- Sponsor's protocol ID
- PI2018106 (EPA-SP)
- Acronym
- AUTENTIC
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03868046
- Acronym / sponsor ID
- AUTENTIC / PI2018106 (EPA-SP)
- Conditions
- Cancer, Metastatic Cancer, Solid Organ Cancer
- Keywords
- Immune-related Adverse Events, Immune Checkpoint Inhibitors, Biomarkers, Autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Hospital Universitario ArabaUniversity, hospital or other
- Collaborators
- Hospital de Basurto, Hospital Donostia, Complejo Hospitalario de Navarra, Hospital Galdakao-Usansolo
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with ICIs. | – | Drug: Treatment with immune checkpoint inhibitors., Diagnostic Test: Blood tests.All enrolled patients must have been diagnosed with a cancer potentially treatable with ipilimumab, nivolumab, pembrolizumab, atezolizumab or avelumab, alone or in combination, per standard protocol. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with cancer amenable to treatment with ICIs will be considered eligible. Potential candidates will be identified and consecutively included in the oncology outpatient clinics of five university hospitals in Spain.
Key inclusion criteria (2 listed)
- Initiation of treatment with a single ICI or a combination of ICIs.
- Acceptation of an informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Patients treated with ICIs. |
| 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. | Diagnostic test | Patients treated with ICIs. |
Primary outcome
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.
4 secondary outcomes
irAE-free survival.
Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.
Progression-free survival.
Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.
Overall survival.
Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.
Incidence of development of autoantibodies.
Time frame: At 24 weeks and at 48 weeks from the initiation of ICIs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Yes. All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iñigo Les Bujanda, MD PhD principal investigator
Hospital Universitario Araba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Metastatic Cancer, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of irAEs. (time frame: At 48 weeks from the initiation of ICIs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.