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

NCT07192315 | Not Yet Recruiting

• 2 other identifiers: RCAPHM25_02942025-A01531-48
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

immuno-induced adverse events; Immune checkpoint inhibitor; baseline predictive signature

Outcome Measures

Primary Outcomes (1)

• Identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE

  The primary endpoint is the identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE among patients who had a severe iRAE (iRAE + patients) and minimize the rate of prediction of severe iRAE among patients who had not a severe iRAE (iRAE- patients), we choose a minimum of 70% of prediction in iRAE + population and a maximum of 15% of prediction in iRAE- population.

  From enrollment to the end of following after 12 months

Secondary Outcomes (12)

• Assesment of safety according to NCI-CTCAE v5.0 criteria

  From enrollment to the end of following after 12 months

• Identification of signatures for severe iRAEs

  From enrollment to the end of following after 12 months

• Identification of signatures for organ-specific severe iRAEs

  From enrollment to the end of following after 12 months

• Identification of signatures for organ-specific severe iRAEs at baseline and T1

  From enrollment to the end of following after 12 months

• Identification of signatures for severe iRAEs in patients receiving anti-PD(L)1 monotherapy.

  From enrollment to the end of following after 12 months

Study Arms (1)

Blood, Throat and skin swabs and Stool additional samples

EXPERIMENTAL

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

Other: Bloodsampling; Other: Pharyngeal swab sampling; Other: Cuteanous swab sampling; Other: Stools sample collection

Interventions

Bloodsampling 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.

Blood, Throat and skin swabs and Stool additional samples

Pharyngeal swab sampling 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)

Blood, Throat and skin swabs and Stool additional samples

Cuteanous swab sampling 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).

Blood, Throat and skin swabs and Stool additional samples

Stools sample collection 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).

Blood, Throat and skin swabs and Stool additional samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (≥18 years old)
• Patient presenting an histologically or cytologically confirmed solid tumour malignancy
• Patient scheduled to receive his/her 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 must have at least one measurable lesion according to RECIST 1.1 criteria
• Patient treated at AP-HM in one of the CEPCM-affiliated departments.
• Patient able to comply with study procedures and follow-up schedule
• Patient who has been informed about the study and signed the consent form
• Patient who is a beneficiary or entitled beneficiary of a social security scheme

You may not qualify if:

• Patient previously treated with ICIs
• Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI
• Patient included in a trial with an experimental molecule
• 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
• Patient with 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.
• Patient in emergency situations, persons deprived of their liberty by judicial or administrative decision, adults subject to legal protection measures, or persons who are unable to give their consent, or pregnant or breastfeeding.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de marseille

Marseille, France

Location

Central Study Contacts

Nausicaa Malissen, dr

CONTACT

0491435817; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 25, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)