2024-519812-15-00RecruitingPhase 4
ETCABio - Evaluation of Skin Tests in Biotherapy Allergies
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Mar 2026
Brief summary (registry, in English)
The primary objective is to determine, in non-allergic patients treated with biotherapy, the maximum non-irritant concentration of the biotherapy that can be used in allergologic skin tests (prick tests and intradermal tests) for patients suspected of hypersensitivity to the said biotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 17 Jun 2026
- Lead sponsor
- Centre Hospitalier Universitaire D'Angers
- Diseases
- Colorectal cancer, Follicular lymphoma, Chronic lymphocytic leukaemia, Mesothelioma, Melanoma, Lung cancer, Amyloidosis, Liver and biliary tract cancer, Hodgkin lymphoma, Gastric and esophageal cancer
- EU CT number
- 2024-519812-15-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 140
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are treated with one of seven biotherapy drugs and have had at least two injections without a suspected allergic reaction. It tests skin tests for drug allergy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Earlier treatment
- Must be treated with Atezolizumab, Nivolumab, Obinutuzumab, Durvalumab, Pembrolizumab, Daratumumab or Cemiplimab. Must have had at least two injections without suspected allergic side effects. Any oral or IV corticosteroids and H1 antihistamines must be stoppable at least one week before the tests.
Main reasons for not taking part
- Skin problems such as psoriasis or eczema that could disturb the skin test results
- Poor understanding of the French language
- Pregnancy or breastfeeding
- Persons in detention by judicial or administrative decision
- Persons under a legal protection measure
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Age
- Pregnancy, breastfeeding* (For women of childbearing age, the absence of pregnancy will be confirmed by a blood pregnancy test (unless already conducted as part of the care or if pregnancy is ruled out).
Other
- 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.
- 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
Who the study is looking for
- Age ≥ 18 years
- Patient treated with one of the biotherapies under study (Atezolizumab, Nivolumab, Obinutuzumab, Durvalumab, Pembrolizumab, Daratumumab, Cemiplimab) 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).
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.