Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)

NCT ID: NCT07192315

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

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 (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation.

The development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice.

We hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies

The objectives are :

Primary objective:

Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected.

Secondary objectives:

• Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected.
• Identify a baseline predictive signature for organ-specific severe iRAE.
• Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data.
• Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy.
• Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination.
• Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received.
• Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed.
• Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients.
• Describe patient-reported outcomes and quality of life parameters.

Conditions

Solid Tumor Malignancies; Solid Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blood, Throat and skin swabs and Stool additional samples

Blood, Throat and skin swabs and Stool additional samples are collected in parallel of treatment administration throughout visits 1 to 4.

Group Type: EXPERIMENTAL

Bloodsampling

Intervention Type: OTHER

Blood will be sampled At Visit 1, 2, 3 and 4. For patients presenting immuno-induced adverse events (iRAEs), an additionnal visit V tox will be planned will a blood sampling.

Pharyngeal swab sampling

Intervention Type: OTHER

Pharyngeal swab will be sampled at visit 4 for patients without immuno-induced adverse events (iRAEs) Pharyngeal swab will be sampled at visit Tox for patients presenting immuno-induced adverse events (iRAEs)

Cuteanous swab sampling

Intervention Type: OTHER

Cuteanous swab will be sampled at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs).

Cuteanous swab will be sampled at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs).

Stools sample collection

Intervention Type: OTHER

Stools sample will be collected at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs).

Stools sample will be collected at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs).

Interventions

Bloodsampling

Blood will be sampled At Visit 1, 2, 3 and 4. For patients presenting immuno-induced adverse events (iRAEs), an additionnal visit V tox will be planned will a blood sampling.

Intervention Type: OTHER

Pharyngeal swab sampling

Pharyngeal swab will be sampled at visit 4 for patients without immuno-induced adverse events (iRAEs) Pharyngeal swab will be sampled at visit Tox for patients presenting immuno-induced adverse events (iRAEs)

Intervention Type: OTHER

Cuteanous swab sampling

Cuteanous swab will be sampled at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs).

Cuteanous swab will be sampled at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs).

Intervention Type: OTHER

Stools sample collection

Stools sample will be collected at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs).

Stools sample will be collected at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de marseille

Marseille, , France

Countries

France

Central Contacts

Nausicaa Malissen, dr

Role: CONTACT

promotion.interne@ap-hm.fr

0491435817 ext. 33

Facility Contacts

Nausicaa Malissen, dr

Role: primary

promotion.interne@ap-hm.fr

0491435817 ext. 33

Other Identifiers

2025-A01531-48

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM25_0294

Identifier Type: -

Identifier Source: org_study_id