Clinical trial · Observational
Understanding and Anticipating Therapeutic Response And Immuno-meDIated Adverse Events in Anti-cancer Immune-checkpoint Inhibition: a Tissue Biopsy Based imaGing Study
- 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)
Immune checkpoint inhibitors (ICI) have dramatically changed the management of some types of metastatic cancer, with indications for their use continuing to expand. Despite the hope brought by these new anti-cancer molecules, the response to ICI in these poorly prognosticated cancers is heterogeneous, with a benefit observed in 20 to 30% of patients, with the combination with chemotherapy or targeted therapies offering new perspectives. By inhibiting natural checkpoints of the immune system, ICI increase the anti-tumor response, but are also responsible for immune-related adverse events (irAEs), which can be severe. There are many hypothesized mechanisms for these immune-related adverse events, but no one has ever characterized in detail the immune infiltrate within the irAEs targeted tissues. In-depth identification of cell subpopulations within the tumor microenvironment, as well as the infiltrate within the irAEs targeted tissues, would allow the identification of new predictive factors of response and toxicity, which could be used in clinical practice at the time of diagnosis. A better understanding of immuno-mediated toxicities would allow to adapt their management, which is currently based on the inflammatory diseases they mimic. The Hyperion technology is an innovative mass cytometry imaging system, allowing the simultaneous analysis of nearly 40 markers within a tissue.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response according to the iRECIST criteria and occurrence of irAE over the duration of the patient's follow-up.
- timeFrame
- 24 months
- description
- Apparition of irAE is appreciated according the physician definition. The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Secondary outcomes (5)
- measure
- CTCAE terminology (description of the adverse event) and grade
- timeFrame
- 24 months
- description
- The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized.
- measure
- Survival (PFS et OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Age ≥ 18 years old * Treated by Immune checkpoint inhibitor (ICI) for an advanced cancer * Treated at Brest University-Hospital, Morlaix Hospital, Quimper Hospital, Clinique Pasteur in Brest or Bordeaux University Hospital * With a tumor or tissue biopsy (organ target of irAEs) archived in sufficient quantity for Hyperion analysis * For the control group: patient with an inflammatory disease (autoimmune, autoinflammatory) who had a biopsy at diagnosis Exclusion Criteria: * Subject of guardianship (tutorship, curatorship) * Refusal to participate * Patient not meeting inclusion criteria for each point
References
Publications (0)
Data not yet available