Clinical trial · Observational
Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)
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
NCT03868046CI-TRIAL-00087945AUTENTICcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Organ Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood tests. | Diagnostic Test | — | UNRESOLVED |
| Treatment with immune checkpoint inhibitors. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated with ICIs.
- description
- 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.
- interventionNames
- Drug: Treatment with immune checkpoint inhibitors.
- Diagnostic Test: Blood tests.
Primary outcomes (1)
- measure
- Incidence of irAEs.
- timeFrame
- At 48 weeks from the initiation of ICIs.
- description
- 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 (4)
- measure
- irAE-free survival.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Initiation of treatment with a single ICI or a combination of ICIs. 2. Acceptation of an informed consent. Exclusion Criteria: 1. Life expectancy lower than 3 months from the initiation of treatment with ICIs. 2. Proven hypersensitivity or previous allergic anaphylactic reaction induced by a specific ICI. 3. Active autoimmune disease with severe involvement. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3. 5. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.