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Evaluation of Skin Tests in Biotherapy Allergies

Study acronym: ETCABIO
StatusRecruiting
PhaseNot applicable
Started2026-06-17
View on ClinicalTrials.gov ↗

Amendment history

2026-06-17
notable
Study Status, Eligibility, Contacts/Locations v6
Recruitment opened
Start dateestimated 2026-06→confirmed 2026-06-17
Eligibility criteria+52 characters
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 biothe [...]
Study sitesdetails revised at 1 of 1 site
2026-06-11
minor
Study Status v5
Primary completion pushed: 2028-05 → 2028-06
Completion pushed: 2028-06 → 2028-07
Start date2026-05→2026-06
2026-03-24
minor
Study Status, Eligibility, IPDSharing v4
Primary completion date2027-09→2028-05
Completion date2027-10→2028-06
Start date2025-09→2026-05
Eligibility criteria-52 characters
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 biothe [...]
2025-07-08
minor
Study Status v3
Primary completion date2027-06→2027-09
Completion date2027-07→2027-10
Start date2025-06→2025-09
2025-05-22
minor
Study Status, Conditions v2
Re-verified, no change to tracked fields
2025-05-16
minor
Study Status, Study Design v1
PhaseEarly Phase 1→Not applicable
2025-05-06
minor
Original filing
2,904 trials monitored
See 127 trials at risk
2,553 trials monitored
See 134 trials at risk
and 10 more diseases
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.
Trial Details
NCT Number NCT06971848
Lead Sponsor University Hospital, Angers
Conditions Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms, Small Cell Bronchial Carcinomas, Bronchial Carcinoma, Pleural Mesothelioma, Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma +8 more
Enrollment 70 participants
Start Date 2026-06-17
Primary Completion 2028-06 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-18