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New treatment option for Melanoma
Official title Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma
ClinicalTrials.gov ID: NCT06240143
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for 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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women, at least 18 years of age;
- World Health Organization (WHO) Performance Status 0 or 1;
- Histologically confirmed, stage pT3-4 cutaneous melanoma (Breslow thickness \>2.0mm; according to AJCC criteria 8th edition);
- Having ≥44% risk for SN positivity as assessed by the MIA Sentinel Node Metastasis Risk prediction tool (melanomarisk.org.au/SNLForm)1;
- Excision of primary melanoma took place ≤4 weeks prior to informed consent;
You likely can't join if
- Acral, uveal/ocular, mucosal or or lentigo maligna melanoma;
- A concurrent second, primary melanoma;
- Regionally or distantly metastasized melanoma, including in-transit metastases and macroscopic lymph node metastases;
- No suspect lymph nodes detectable by ultrasound in the draining lymph node region(s);
- people with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or...
- Prior surgery, including prior sentinel node procedure or lymph node dissection, in the affected lymph node region(s);
See the full eligibility criteria
- Men and women, at least 18 years of age;
- World Health Organization (WHO) Performance Status 0 or 1;
- Histologically confirmed, stage pT3-4 cutaneous melanoma (Breslow thickness \>2.0mm; according to AJCC criteria 8th edition);
- Having ≥44% risk for SN positivity as assessed by the MIA Sentinel Node Metastasis Risk prediction tool (melanomarisk.org.au/SNLForm)1;
- Excision of primary melanoma took place ≤4 weeks prior to informed consent;
- Naïve for re-excision of the primary melanoma site and for sentinel node procedure;
- No other solid, distantly metastasized malignancies, no hematological malignancies and no malignancies for which systemic treatment is administered within 6 months prior to study inclusion;
- No prior immunotherapy targeting CTLA-4, PD-1, PD-L1 or LAG-3;
- No prior targeted therapy with BRAF/MEK inhibition;
- No immunosuppressive medications within 6 months prior to study inclusion (steroids equivalent to prednisolone ≤10 mg are allowed);
- Screening laboratory values must meet the following criteria: WBC ≥2.0x109/L, neutrophils ≥1.5x109/L, platelets ≥100x109/L, hemoglobin ≥5.5 mmol/L, creatinine ≤1.5xupper limit of normal (ULN), AST ≤1.5x ULN, ALT ≤1.5x...
- LDH level ≤ULN;
- Women of childbearing potential (WOCP) must use appropriate method(s) of contraception, i.e. methods with a failure rate of \<1% per year when used consistently and correctly, to avoid pregnancy for 23 weeks post last...
- Patient willing and able to understand the protocol requirements and comply with the treatment schedule, scheduled visits, electronic patient outcome reporting, tumor biopsies and extra blood withdrawal during...
- Acral, uveal/ocular, mucosal or or lentigo maligna melanoma;
- A concurrent second, primary melanoma;
- Regionally or distantly metastasized melanoma, including in-transit metastases and macroscopic lymph node metastases;
- No suspect lymph nodes detectable by ultrasound in the draining lymph node region(s);
- people with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. people with resolved childhood...
- Prior surgery, including prior sentinel node procedure or lymph node dissection, in the affected lymph node region(s);
- Prior radiotherapy targeting the affected lymph node region(s);
- people will be excluded if they test positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. people treated and being at least...
- people will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- people with history of allergy to study drug components or history of severe hypersensitivity reaction to monoclonal antibodies;
- people with underlying medical conditions or active infection that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events;
- Women who are pregnant or breastfeeding;
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids \>10 mg prednisolone daily equivalent;
- Use of other investigational drugs before study drug administration 30 days or 5 half-times before study inclusion;
- Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before...
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Groningen, Netherlands; Leiden, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
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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.