Actively Recruiting
Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma
Led by The Netherlands Cancer Institute · Updated on 2024-11-14
96
Participants Needed
6
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open label, single country trial will test if local injection of low-dose ipilimumab and nivolumab, is safe and reduces the sentinel node positivity in high-risk stage II melanoma patients.
CONDITIONS
Official Title
Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women at least 18 years old
- WHO Performance Status of 0 or 1
- Histologically confirmed stage pT3-4 cutaneous melanoma (Breslow thickness >2.0mm)
- At least 4% risk of sentinel node positivity by MIA risk tool
- Primary melanoma excised within 4 weeks before consent
- No prior re-excision or sentinel node procedure
- No other solid or hematologic malignancies requiring systemic treatment within 6 months
- No prior immunotherapy targeting CTLA-4, PD-1, PD-L1, or LAG-3
- No prior targeted therapy with BRAF/MEK inhibitors
- No immunosuppressive medications within 6 months (steroids ≤10 mg prednisolone allowed)
- Laboratory values within specified limits for blood counts, liver and kidney function
- LDH level at or below normal limit
- Women of childbearing potential must use highly effective contraception during and 23 weeks after treatment
- Willing and able to comply with study procedures and visits
You will not qualify if you...
- Acral, uveal/ocular, mucosal, or lentigo maligna melanoma
- Concurrent second primary melanoma
- Regionally or distantly metastasized melanoma including in-transit and macroscopic lymph node metastases
- No suspicious lymph nodes detectable by ultrasound in draining region
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressive treatment (except certain mild conditions)
- Prior surgery or radiotherapy in affected lymph node region
- Positive for hepatitis B surface antigen or active hepatitis C infection
- Known HIV infection or AIDS
- Allergy or severe reaction to study drug components or monoclonal antibodies
- Medical conditions or infections making study treatment unsafe or unclear
- Pregnant or breastfeeding women
- Use of immunosuppressive medications or high-dose corticosteroids
- Use of other investigational drugs within 30 days or 5 half-lives
- Psychological, familial, sociological, or geographical conditions affecting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Amsterdam University Medical Center
Amsterdam, Netherlands
Not Yet Recruiting
2
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Actively Recruiting
3
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
4
Leiden University Medical Center
Leiden, Netherlands
Not Yet Recruiting
5
Erasmus University Medical Center
Rotterdam, Netherlands
Not Yet Recruiting
6
University Medical Center Utrecht
Utrecht, Netherlands
Not Yet Recruiting
Research Team
C
Christian Blank, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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