Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckETCABIONCT06971848
Evaluation of Skin Tests in Biotherapy Allergies
A study testing Drug skin tests (investigating hypersensitivity to a biotherapy) in people with Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck and Melanoma Neoplasms, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms, Small Cell Bronchial Carcinomas
- What is being tested?
- Drug skin tests (investigating hypersensitivity to a biotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2026to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, 49933
Martine MORISSET, 02 41 35 36 37 ext. +33, martine.morisset@chu-angers.fr
Dominique LUET
About this study
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.
- 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
- Being tested
- Drug skin tests (investigating hypersensitivity to a biotherapy)
- Medical subject headings
- Carcinoma, Bronchogenic, Mesothelioma, Malignant, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Neoplasms, Plasma Cell, Immunoglobulin Light-chain Amyloidosis, Carcinoma, Hepatocellular, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug skin tests (investigating hypersensitivity to a biotherapy)Other
allergologic skin tests (prick tests and intradermal tests)
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Not described Receives: Other: Drug skin tests (investigating hypersensitivity to a biotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum usable concentration considered non-irritant
For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.
Measured: Day 1
Secondary outcomes (2)
possible occurrence of a delayed reaction at 48 hours post-testing
delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours after injection, or if a systemic reaction occurs following biotherapy administration.
Measured: Day 2
possible occurrence of a delayed reaction at one week post-testing
delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 1 week after injection
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start17 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martine MORISSET, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971848
- Sponsor's protocol ID
- 49RC24_0373
- Acronym
- ETCABIO
- Status last verified
- Jun 2026
- First submitted
- 6 May 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.