Uveal MelanomaPhase 1NCT07501117
Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma
A Phase 1 study testing Nivolumab & Ipilimumab in people with Uveal Melanoma, run by Inge Marie Svane at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Nivolumab & Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Jun 2026to 1 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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 level > 1,5 ULN, c) Serum creatinine ≤1,5 X ULN, d) ANC (Absolute Neutrophil Count) ≥1,000/mcL, e) Platelets ≥ 75,000 /mcL, f) Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
- Signed statement of consent after receiving oral and written study information
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- 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.
- The following is considered highly effective methods of contraception: 1. Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal or transdermal), 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 3. Intrauterine device (IUD) 4. intrauterine hormone-releasing system (IUS) 5. Bilateral tubal occlusion, 6. Vasectomised partner provided that the vasectomy is confirmed successful, 7. Sexual abstinence defined as refraining from heterosexual intercourse. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods.
- Men with female partner of childbearing potential must: 1. Use a condom during sexual intercourse from screening and until 6 months after treatment. 2.
- Ensure that their partner uses a highly effective method of contraception (as described above) 3. Agree to refrain from sperm donation, storage, or banking
Who cannot join
- 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
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital
Herlev, Herlev, 2730
Tine Juul Monberg, MD, PhD, 004538683868, tine.monberg@regionh.dk
About this study
Official title: Neoadjuvant Ipilimumab and Nivolumab for Patients With High-risk Uveal Melanoma
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.
- Conditions
- Uveal Melanoma
- Being tested
- Nivolumab & Ipilimumab
- Keywords
- Immunotherapy, Neoadjuvant therapy, High-risk uveal melanoma, Nivolumab, Ipilimumab
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab & IpilimumabDrug
Nivolumab 3 mg/kg Ipilimumab 1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant nivolumab + ipilimumab | Experimental | Neoadjuvant nivolumab + ipilimumab Receives: Drug: Nivolumab & Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs)
Safety is evaluated by the Common Terminology Criteria (CTCAE) for Adverse Events version 6.0 and include the number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs) until 6 months post treatment.
Measured: Until 6 months post treatment
Proportion of patients who complete the treatment regimen
Feasibility is evaluated as the proportion of patients who complete the treatment regimen defined as receiving at least one dose of both nivolumab and ipilimumab, followed by enucleation
Measured: Until 6 months post treatment
Secondary outcomes (4)
Pathological response rate
The fraction of pathological responses according to standard evaluation criteria
Measured: through study completion, an average of 3 years
Objective response
Size and extend of the tumor at baseline and after the second dose of nivolumab and ipilimumab.
Measured: through study completion, an average of 3 years
Distant metastases free survival (DMFS)
DMFS will be evaluated as the time from treatment initiation to the development of any distant metastasis or death.
Measured: Until 6 months post treatment
Overall survival (OS)
OS will be evaluated as the time from treatment initiation to death from any cause
Measured: Until 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start29 Jun 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501117
- Sponsor's protocol ID
- MM2530
- Other IDs
- 2025-524526-18-00, 2025
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Ipilimumab and Nivolumab for Patients With High-risk Uveal Melanoma
- ClinicalTrials.gov ID
- NCT07501117
- Acronym / sponsor ID
- MM2530
- Conditions
- Uveal Melanoma
- Keywords
- Immunotherapy, Neoadjuvant therapy, High-risk uveal melanoma, Nivolumab, Ipilimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant nivolumab + ipilimumab | Experimental | Drug: Nivolumab & IpilimumabNeoadjuvant nivolumab + ipilimumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
- 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 level > 1,5 ULN, c) Serum creatinine ≤1,5 X ULN, d) ANC (Absolute Neutrophil Count) ≥1,000/mcL, e) Platelets ≥ 75,000 /mcL, f) Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
Key exclusion criteria (10 listed)
- 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
- The patient has an active infection requiring systemic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab & IpilimumabNivolumab 3 mg/kg Ipilimumab 1 mg/kg | Drug | Neoadjuvant nivolumab + ipilimumab |
Primary outcome
Number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs)
Time frame: Until 6 months post treatment
Safety is evaluated by the Common Terminology Criteria (CTCAE) for Adverse Events version 6.0 and include the number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs) until 6 months post treatment.
Proportion of patients who complete the treatment regimen
Time frame: Until 6 months post treatment
Feasibility is evaluated as the proportion of patients who complete the treatment regimen defined as receiving at least one dose of both nivolumab and ipilimumab, followed by enucleation
4 secondary outcomes
Pathological response rate
Time frame: through study completion, an average of 3 years
Objective response
Time frame: through study completion, an average of 3 years
Distant metastases free survival (DMFS)
Time frame: Until 6 months post treatment
Overall survival (OS)
Time frame: Until 6 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab & Ipilimumab in people with Uveal Melanoma, run by Inge Marie Svane at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inge Marie Svane, Professor, MD (004538683868, inge.marie.svane@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs) (time frame: Until 6 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.