Understanding immunE-related toXicities by multifACeT Profiling
ConditionOncology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this trial
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
The study aims to enroll and obtain samples of investigational interest from 200 patients with a confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Patients who experience irAEs
To determine the proportion of patients who experience irAEs during treatment with CPI.
Time frame
36 monthsSecondary outcomes
1
Biological and clinical characteristics
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 frame
60 months2
Time to development of irAEs
To determine time to clinical development of irAEs during treatment with CPI.
Time frame
36 months3
Proportion of patients experiencing irAEs
• To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.
Time frame
60 monthsOther outcomes
1
Impact on patients quality of life using patient questionnaires
• Explore the quality-of-life impact on patients enrolled in longitudinal multi-facet disease profiling and in patients who develop irAEs.
Time frame
60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov