Clinical trial • Not applicable • Oncology

ATEZOLIZUMAB for deficient mismatch repair (dMMR) colorectal cancer|Follicular lymphoma|Chronic lymphocytic leukemia|Pleural mesothelioma|Melanoma|Small cell lung carcinoma|AL amyloidosis|Hepatocellular carcinoma|Hodgkin lymphoma|Cholangiocarcinoma|Locally advanced cutaneous squamous cell carcinoma|Non-small cell lung carcinoma|deficient mismatch repair (dMMR) colorectal adenocarcinoma|Esophageal squamous cell carcinoma|Gastric cardia cancer|Myeloma

Not applicable trial of ATEZOLIZUMAB for deficient mismatch repair (dMMR) colorectal cancer|Follicular lymphoma|Chronic lymphocytic leukemia|Pleural mesot…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
deficient mismatch repair (dMMR) colorectal cancer|Follicular lymphoma|Chronic lymphocytic leukemia|Pleural mesothelioma|Melanoma|Small cell lung carcinoma|AL amyloidosis|Hepatocellular carcinoma|Hodgkin lymphoma|Cholangiocarcinoma|Locally advanced cutaneous squamous cell carcinoma|Non-small cell lung carcinoma|deficient mismatch repair (dMMR) colorectal adenocarcinoma|Esophageal squamous cell carcinoma|Gastric cardia cancer|Myeloma
Trial Stage
Not applicable
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
28-01-2025
First CTIS Authorization Date
10-04-2025

Trial design

None/Not specified-controlled Not applicable trial in France.

Comparator
None/Not specified
Target Sample Size
140
Trial Duration For Participant
7

Eligibility

Recruits 140 Vulnerable populations are specifically considered: persons in detention, persons subject to legal protection measures, and persons admitted to health or social establishments for purposes other than research are excluded. Written informed consent is required from each subject (adults only, as minimum age is 18). No pediatric assent/consent procedures are provided because inclusion is limited to adults. Consent documents are available (subject information and informed consent form documents are present in French)..

Pregnancy Exclusion
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).
Vulnerable Population
Vulnerable populations are specifically considered: persons in detention, persons subject to legal protection measures, and persons admitted to health or social establishments for purposes other than research are excluded. Written informed consent is required from each subject (adults only, as minimum age is 18). No pediatric assent/consent procedures are provided because inclusion is limited to adults. Consent documents are available (subject information and informed consent form documents are present in French).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Subjects covered by or having the rights to medical care assurance"}
  • {"criterion_text":"- Written informed consent obtained from subject"}
  • {"criterion_text":"- 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

  • {"criterion_text":"- Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests."}
  • {"criterion_text":"- Poor understanding of the French language."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Persons in detention by judicial or administrative decision"}
  • {"criterion_text":"- Person admitted to a health or social establishment for purposes other than research"}
  • {"criterion_text":"- Person subject to a legal protection measure"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"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 by skin testing (prick tests and intradermal tests) and assessment of presence/absence of skin reaction."}

Secondary endpoints

  • {"endpoint_text":"- A delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours or one week after injection, or if a systemic reaction occurs following biotherapy administration. Patients will be contacted by phone to confirm the presence or absence of a delayed local reaction, and if necessary, a photograph taken during a consultation with the allergologist investigator or in a video consultation will confirm the reaction.","definition_or_measurement_approach":"Delayed reaction defined by occurrence of skin reaction at 48 hours or 1 week post-injection or systemic reaction; detection via patient phone contact and confirmation by photograph during in-person or video consultation with the allergologist investigator."}

Recruitment

Planned Sample Size
140
Recruitment Window Months
25
Consent Approach
Written informed consent obtained from each subject (adults ≥18). Subject information and informed consent form documents are provided in French (fr-FR). No pediatric assent procedures (min age 18).

Geography

Total Number Of Sites
5
Total Number Of Participants
140

France

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
366
Number Of Sites
5
Number Of Participants
140

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Gastroenterologie, Endoscopie & Oncologie digestive
Principal Investigator Name
Dominique LUET
Principal Investigator Email
doluet@chu-angers.fr
Contact Person Name
Dominique LUET
Contact Person Email
doluet@chu-angers.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Dermatologie
Principal Investigator Name
Yannick LE CORRE
Principal Investigator Email
YaLeCorre@chu-angers.fr
Contact Person Name
Yannick LE CORRE
Contact Person Email
YaLeCorre@chu-angers.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Allergologie
Principal Investigator Name
Martine MORISSET
Principal Investigator Email
martine.morisset@chu-angers.fr
Contact Person Name
Martine MORISSET
Contact Person Email
martine.morisset@chu-angers.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Pneumologie
Principal Investigator Name
Youssef OULKHOUIR
Principal Investigator Email
Youssef.Oulkhouir@chu-angers.fr
Contact Person Name
Youssef OULKHOUIR
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Maladies du sang
Principal Investigator Name
Jonathan FARHI
Principal Investigator Email
Jonathan.Farhi@chu-angers.fr
Contact Person Name
Jonathan FARHI
Contact Person Email
Jonathan.Farhi@chu-angers.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire D'Angers
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ATEZOLIZUMAB
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml
Investigational Product Name
NIVOLUMAB
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml
Investigational Product Name
OBINUTUZUMAB
Active Substance
OBINUTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml
Investigational Product Name
DURVALUMAB
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml
Investigational Product Name
DARATUMUMAB
Active Substance
DARATUMUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml
Investigational Product Name
CEMIPLIMAB
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Maximum Dose
0.4 ml

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