Status:
NOT_YET_RECRUITING
Evaluation of Skin Tests in Biotherapy Allergies
Lead Sponsor:
University Hospital, Angers
Conditions:
Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Melanoma Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06971848
Start Date
September 1 2025
End Date
October 1 2027
Last Update
July 11 2025
Active Locations (1)
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1
CHU Angers
Angers, France, 49933