MITAZALIMAB for Oral potentially malignant disorder | Oral disorders

Inclusion criteria

• {"criterion_text":"- Signed written informed consent"}
• {"criterion_text":"- Male or female > 18 years of age"}
• {"criterion_text":"- ECOG Performance status (PS) 0-2"}
• {"criterion_text":"- Diagnosis of high risk OPMD (i.e. leucoplakia, erhytroplakia, erhytro-leukoplakia) as defined by any of the following criteria: a.\tOPMD with multifocal (≥2), or contiguous lesions of ≥ 3 cm, or a single lesion ≥ 4 cm or greater in largest diameter with at least 1 lesion with epithelial dysplasia (any degree) b.\tOPMD with 4-quadrant oral cavity involvement (any grade of dysplasia) c.\tOPMD in at least one lesion with moderate dysplasia (at least grade 2) d.\tOPMD with high risk dysplasia (G3) (WHO classification - Reibel at al. 2017)"}
• {"criterion_text":"- OPMD with a minimal diameter of 2 cm"}
• {"criterion_text":"- Be willing to provide tissue from newly obtained oral biopsies"}
• {"criterion_text":"- Be willing to provide saliva samples for study purposes"}
• {"criterion_text":"- Prior oral cavity squamous cell carcinoma will be allowed, provided there is an interval of at least 2 years since completion of their previous treatment."}

Exclusion criteria

• {"criterion_text":"- Previous immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, CD40 agonist, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint receptors);"}
• {"criterion_text":"- Oral lesions due to histology confirmed Lichen Planus or GVHD (suspicious lichenoid lesions will be evaluated with the medical monitor);"}
• {"criterion_text":"- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy, or known HIV or acquired immunodeficiency syndrome (AIDS)-related illness"}
• {"criterion_text":"- Vaccination within 4 weeks of the first dose of mitazalimab and while on trial is prohibited except for the administration of inactivated vaccines (for example, inactivated influenza vaccines);"}
• {"criterion_text":"- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled; hypertension, or history of myocardial infarction in the last 12 months"}

Primary endpoints

• {"endpoint_text":"- Best overall response rate (CR + PR rate) at 6 months, as defined by the percent change in clinical-pathologic composite score","definition_or_measurement_approach":"As defined by the percent change in clinical-pathologic composite score (primary endpoint text provides the measurement approach)."}

Secondary endpoints

• {"endpoint_text":"- •\tEvaluate 3 years and overall malignant transformation rate •\tMeasure drug-induced adverse events and any treatment interruption due to toxicities •\tEvaluate the change of histological grading of OPMD (based on the World Health Organization WHO classification)","definition_or_measurement_approach":""}
• {"endpoint_text":"- •\tAssess patient reported outcomes, measured via PRO CTCAE at treatment start, at 6 months and then every three months for the following 18 months. Questionnaire will be derived by the NCI- PRO-CTCAE ITEMS-ITALIAN •\tTo assess impact on patients’ quality of life, measured via EORTC QLQC30-HN43","definition_or_measurement_approach":"Patient-reported outcomes measured via PRO-CTCAE at specified timepoints; QoL measured via EORTC QLQ-C30 and HN43."}
• {"endpoint_text":"- Exploratory Endpoints •\tCorrelate selected biomarkers in tissue and saliva with malignancy-free survival. •\tAssess narrow-band imaging (NBI) changes during the study treatment and follow up","definition_or_measurement_approach":"Correlation of selected tissue and saliva biomarkers with malignancy-free survival; assessment of NBI imaging changes during treatment and follow-up."}
• {"endpoint_text":"- •\tTo evaluate the LOH status (to be considered positive in patients carrying OPMD with LOH at 3p14 and/or 9p21 plus at least at one additional chromosomal site (4q, 8p,11p,13q, or 17p) or in patients carrying OPMD with a prior oral cancer history and LOH at 3p14 and/or 9p21 (LOH defined according to EPOC trial) at baseline, at 6 months, and in case of malignant transformation.","definition_or_measurement_approach":"LOH defined according to EPOC trial; evaluated at baseline, at 6 months, and at malignant transformation; considered positive if LOH at 3p14 and/or 9p21 plus at least one additional site (4q,8p,11p,13q,17p) or prior oral cancer history with LOH at 3p14 and/or 9p21."}

Other endpoints

• {"endpoint_text":"- Exploratory Endpoints •\tCorrelate selected biomarkers in tissue and saliva with malignancy-free survival. •\tAssess narrow-band imaging (NBI) changes during the study treatment and follow up","definition_or_measurement_approach":"Correlation of selected tissue and saliva biomarkers with malignancy-free survival; assessment of NBI imaging changes during treatment and follow-up."}

Italy

Earliest CTIS Part Ii Submission Date

06-06-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

334

Number Of Sites

5

Number Of Participants

31

Primary sponsor

Full Name

Humanitas Mirasole S.p.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Contract research organisations

Name

Clinical Research Technology S.r.l.

Responsibilities

sponsorDuties codes: 1,12,5,6,7,8

Third parties

• {"country":"Italy","full_name":"Clinical Research Technology S.r.l.","duties_or_roles":"sponsorDuties codes: 1,12,5,6,7,8","organisation_type":"Pharmaceutical company"}