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Immunological variables associated to ICI toxicity in cancer patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505360-11-00
Acronym
IJB-IRAES-2020
Enrollment
441
Registered
2023-07-03
Start date
2022-08-18
Completion date
Unknown
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

solid tumour

Brief summary

Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Interventions

DRUGATEZOLIZUMAB
DRUGDURVALUMAB
DRUGAVELUMAB
DRUGOXALIPLATIN
DRUGIPILIMUMAB
DRUGAXITINIB
DRUGsolution à diluer pour perfusion
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGPEGFILGRASTIM
DRUGCETIRIZINE
DRUGFLUOROURACIL
DRUGCABOZANTINIB
DRUGPEMBROLIZUMAB
DRUGPACLITAXEL
DRUGNIVOLUMAB
DRUGPEMETREXED
DRUGETOPOSIDE
DRUGALIZAPRIDE
DRUGCISPLATIN
DRUGDEXAMETHASONE SODIUM PHOSPHATE
DRUGBEVACIZUMAB
DRUGCALCIUM FOLINATE
DRUGCEMIPLIMAB

Sponsors

Institut Jules Bordet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026