Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma
ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInge Marie Svane
About this trial
The goal of this clinical trial is to investigate the safety and feasibility of neoadjuvant immunotherapy for patients with high-risk uveal melanoma. The main question is:
\- Is neoadjuvant treatment with nivolumab and ipilimumab safe and feasible for patientt with high-riks uveal melanoma? In addition pathological response, distant metastases-free survival, overall survival and immunological changes in the tumor microenviroenment after therapy will be assesed.
Eligibility criteria
Qualifiers
Age ≥ 18 ≤ 80
The patient is able to read and understand Danish.
Primary, localized and treatment-naive uveal melanoma planned for enucleation (high risk/T3-T4) and available for transvitreal biopsies. The initial diagnosis of uveal melanoma is based on ophthalmologic and clinical findings.
ECOG performance status of 0 or 1 (appendix 2)
Disqualifiers
A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.
Requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening
The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
The patient is pregnant or breastfeeding
Trial design
Treatments tested in this trial
- Nivolumab & Ipilimumab
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Inge Marie Svane
Lead sponsor
Herlev Hospital
Sponsor institution
Source ClinicalTrials.gov