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New treatment option for Uveal Melanoma
Official title Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma
ClinicalTrials.gov ID: NCT07501117
What this study is testing
What is Nivolumab & Ipilimumab?
Nivolumab & Ipilimumab is an investigational medicine, being studied as a potential treatment for uveal melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- ECOG performance status of 0 or 1 (appendix 2)
- The patient meets the following haematological and biochemical criteria at time of screening: a) AST and ALT ≤2,5 X ULN, b) Serum total bilirubin...
You likely can't join if
- A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2...
- Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within...
- The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse...
- The patient is pregnant or breastfeeding
- The patient has an active infection requiring systemic therapy
- Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or...
See the full eligibility criteria
- 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...
- ECOG performance status of 0 or 1 (appendix 2)
- The patient meets the following haematological and biochemical criteria at time of screening: a) AST and ALT ≤2,5 X ULN, b) Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total bilirubin...
- Signed statement of consent after receiving oral and written study information
- Willingness to participate in the planned treatment and follow-up schedule
- For women of childbearing potential (WOCBP) a negative serum pregnancy test at time of screening and the use of highly effective contraception is required. This applies from screening and until 6 months after treatment...
- 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. people with curatively treated ductal carcinoma in...
- 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
- The patient has an active infection requiring systemic therapy
- Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus.
- Concurrent treatment with other experimental drugs
- Any significant active autoimmune disease
- Severe allergy or anaphylactic reactions earlier in life
- Known hypersensitivity to one of the active drugs or one or more of the excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Herlev, Denmark
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Herlev, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.