Evaluation of Skin Tests in Biotherapy Allergies (NCT06971848) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Skin Tests in Biotherapy Allergies
France70 participantsStarted 2026-06-17
Plain-language summary
Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.
These biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).
Unlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.
* Subjects covered by or having the rights to medical care assurance
* Written informed consent obtained from subject
* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).
Exclusion Criteria:
* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.
* Poor understanding of the French language
* Pregnancy, breastfeeding
* Persons in detention by judicial or administrative decision
* Person admitted to a health or social establishment for purposes other than research
* Person subject to a legal protection measure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing skin tests for biotherapy allergies across a wide range of cancers including my type — can you explain what a 'biotherapy allergy' actually is, and whether I might be at risk of one with my current or planned treatment?
2The trial's main goal is to find the highest concentration of a substance that doesn't irritate the skin — since this is a diagnostic or safety-testing study rather than a treatment trial, how would participating actually affect my cancer care, if at all?
3This trial isn't recruiting yet — if it becomes relevant to me, how would you know whether the biotherapy I'm receiving is one being evaluated in this study, and would timing matter given where I am in my treatment?
4If this study is about identifying safe concentrations for allergy skin testing in biotherapy patients, does that mean there's a known risk of allergic reactions to the biologics used for my cancer, and should I already be monitored or tested for that outside of a trial?
5Since this isn't a treatment trial and has no assigned phase, what would be the practical benefit to me personally of enrolling — and is there any standard approach already available for testing biotherapy allergies that my care team uses?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
maximum usable concentration considered non-irritant