Understanding immunE-related toXicities by multifACeT Profiling

Recruiting

• Conditions: Oncology

• Registration Number: NCT05331066
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.

Detailed Description

The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.

Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.

IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.

Study Timeline

• Study Start: 2022-04-06
• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2028-04-06
• Study Completion: 2028-04-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Written informed consent
• Age 18 years or older
• Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy

Exclusion Criteria

• Medical or psychological condition that would preclude informed consent
• Planned participation in a drug trial receiving investigational agents
• Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.
• Subjects unable to comply with the study or sample schedule.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients who experience irAEs	36 months	To determine the proportion of patients who experience irAEs during treatment with CPI.

Secondary Outcome Measures

Name	Time	Method
Biological and clinical characteristics	60 months	To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs).
Time to development of irAEs	36 months	To determine time to clinical development of irAEs during treatment with CPI.
Proportion of patients experiencing irAEs	60 months	• To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Chelsea, London, United Kingdom