Status:
NOT_YET_RECRUITING
Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Solid Tumor Malignancies
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (i...
Eligibility Criteria
Inclusion
- Adults (≥18 years old)
- Histologically or cytologically confirmed solid tumour malignancy
- Patients are included in the study before their first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.
- Patient treated at AP-HM in one of the CEPCM-affiliated departments.
- Inclusions will be made such that at least 40% of included patients receive a combination of ICIs
- Ability to comply with study procedures and follow-up schedule
- The patient must have given free and informed consent and signed the consent form
- Patient must have at least one measurable lesion according to RECIST 1.1 criteria
- Patient who is a beneficiary or entitled beneficiary of a social security scheme
Exclusion
- Patients previously treated with ICIs
- The patient's therapeutic plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI
- Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug
- Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Patients of Adults without legal capacity
- Patients in Health and Social Establishments
- Persons in emergency situations
- Persons deprived of their liberty
- Absence or refusal of the informed consent
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07192315
Start Date
January 1 2026
End Date
January 1 2028
Last Update
November 20 2025
Active Locations (1)
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1
Assistance Publique Hôpitaux de marseille
Marseille, France