deficient mismatch… · Phase IV (2024-519812-15-00)

Status Authorised, recruitment pending · 1 EU/EEA countries · 5 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Authorised, recruitment pending

Participants planned 140

Countries 1

Sites 5

deficient mismatch repair (dMMR) colorectal cancer

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.

Key facts

Sponsor: Centre Hospitalier Universitaire D'Angers
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2025-04-10
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Secondary objectives 1

The secondary objective is to assess the possible occurrence of a delayed reaction at 48 hours and one week post-testing.

Conditions and MedDRA coding

deficient mismatch repair (dMMR) colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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).

Exclusion criteria 6

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* (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).
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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.

Secondary endpoints 1

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Obinutuzumab

SCP276011 · ATC

Active substance: Obinutuzumab
Substance synonyms: RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L01XC15 — OBINUTUZUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Nivolumab

SCP8265340 · ATC

Active substance: Nivolumab
Substance synonyms: BMS936558, ABP 206
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L01FF01 — NIVOLUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Atezolizumab

SCP65091812 · ATC

Active substance: Atezolizumab
Substance synonyms: RO5541267
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L01FF05 — ATEZOLIZUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Durvalumab

SCP31706250 · ATC

Active substance: Durvalumab
Substance synonyms: MEDI4736
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L01FF03 — DURVALUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cemiplimab

SUB189482 · Substance

Active substance: Cemiplimab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pembrolizumab

SCP6094344 · ATC

Active substance: Pembrolizumab
Substance synonyms: Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, CT P51, SYS6036, QL-2107, ABP 234
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L01FF02 — PEMBROLIZUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daratumumab

SCP12565263 · ATC

Active substance: Daratumumab
Substance synonyms: HuMax-CD38
Route of administration: OTHER USE
Max daily dose: 0.4 ml millilitre(s)
Max total dose: 0.4 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L01FC01 — DARATUMUMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire D'Angers

Sponsor organisation: Centre Hospitalier Universitaire D'Angers
Address: 4 Rue Larrey
City: Angers
Postcode: 49100
Country: France

Scientific contact point

Organisation: Centre Hospitalier Universitaire D'Angers
Contact name: investigator coordinnating

Public contact point

Organisation: Centre Hospitalier Universitaire D'Angers
Contact name: Chef de projet

Locations

1 EU/EEA country · 5 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	140	5
Rest of world	—	0	—