BridgeMD
ImmunotherApy for the Prevention of High-Risk Oral DIsorders malignanT transformation - APHRODITE trial
EU CTIS ID: 2025-521490-13-00
What this study is testing
The primary objective is to evaluate the activity of a short course of intralesional immunotherapy with mitazalimab on high risk OPMD (Oral Potentially Malignant Disorder)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent
- Male or female > 18 years of age
- ECOG Performance status (PS) 0-2
- Diagnosis of high risk OPMD (i.e. leucoplakia, erhytroplakia, erhytro-leukoplakia) as defined by any of the following criteria: a. OPMD 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. OPMD with 4-quadrant oral cavity involvement (any grade of dysplasia) c. OPMD in at least one lesion with moderate dysplasia (at least grade 2) d. OPMD with high risk dysplasia (G3) (WHO classification - Reibel at al. 2017)
- OPMD with a minimal diameter of 2 cm
- Be willing to provide tissue from newly obtained oral biopsies
You likely can't join if
- 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);
- Oral lesions due to histology confirmed Lichen Planus or GVHD (suspicious lichenoid lesions will be evaluated with the medical monitor);
- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy, or known HIV or acquired immunodeficiency syndrome (AIDS)-related illness
- 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);
- 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
See the full eligibility criteria
- Signed written informed consent
- Male or female > 18 years of age
- ECOG Performance status (PS) 0-2
- Diagnosis of high risk OPMD (i.e. leucoplakia, erhytroplakia, erhytro-leukoplakia) as defined by any of the following criteria: a. OPMD 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. OPMD with 4-quadrant oral cavity involvement (any grade of dysplasia) c. OPMD in at least one lesion with moderate dysplasia (at least grade 2) d. OPMD with high risk dysplasia (G3) (WHO classification - Reibel at al. 2017)
- OPMD with a minimal diameter of 2 cm
- Be willing to provide tissue from newly obtained oral biopsies
- Be willing to provide saliva samples for study purposes
- 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.
- 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);
- Oral lesions due to histology confirmed Lichen Planus or GVHD (suspicious lichenoid lesions will be evaluated with the medical monitor);
- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy, or known HIV or acquired immunodeficiency syndrome (AIDS)-related illness
- 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);
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.