Clinical trial · Observational
Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
- 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)
This observational study aims to comprehensively characterize immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy in cancer patients and to evaluate the safety and clinical outcomes of ICI rechallenge following irAE resolution. In addition to detailed clinical data collection, the study incorporates biospecimen acquisition, when clinically indicated and feasible, including peripheral blood and organ-specific specimens (e.g., bronchoalveolar lavage fluid for ICI-related pneumonitis, liver biopsy tissue for ICI-related hepatitis, and other relevant clinical specimens). These samples will support exploratory immunologic and molecular analyses to better understand mechanisms underlying irAE development, resolution, and recurrence after rechallenge. This study is designed to generate real-world evidence to improve risk stratification, toxicity management, and decision-making regarding immunotherapy continuation or re-initiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune-Related Adverse Events | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients With Immune-Related Adverse Events After Cancer Immunotherapy
- interventionNames
- Drug: Immune Checkpoint Inhibitors
Primary outcomes (1)
- measure
- Incidence and Clinical Characteristics of Immune-Related Adverse Events During ICI Therapy
- timeFrame
- From initiation of ICI therapy through last follow-up (up to 24 months)
- description
- To evaluate the incidence, organ involvement, severity (CTCAE grading), timing of onset, and management patterns of immune-related adverse events occurring during immune checkpoint inhibitor therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (≥18 years old) with a diagnosis of malignant tumor. * Received treatment with immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 agents). * Developed documented immune-related adverse events (irAEs) during ICI therapy, as determined by treating physicians. * Availability of clinical data for evaluation of irAE characteristics and outcomes. Exclusion Criteria: * Patients receiving ICIs outside of the participating institution without accessible clinical records. * Insufficient clinical information to determine irAE diagnosis or outcomes. * Patients who decline use of their clinical data or biospecimens, when applicable.
References
Publications (0)
Data not yet available