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New treatment option for Melanoma Metastatic
Official title Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma
ClinicalTrials.gov ID: NCT06880198
What this study is testing
- What it's testing
- This is a monocentric, prospective study evaluating the effectiveness in reducing immune-related adverse events, and translational study conducted on 20 patients with inoperable locally advanced or metastatic melanoma. The patients will be treated with Oral Impact® administered at the dose of two bricks/day for 21 days + one brick/day for 14 days, starting exactly one week before Anti PD-1 treatment (nivolumab) or anti PD1 based regimen therapy (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) as per clinical practice.
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
- Age ≥ 18 years;
- Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma;
- PD-L1 evaluation and as per standard clinical practice, patients with PD-L1 \ 1% will be treated with anti-PD1 in monotherapy;
- Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and...
- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
You likely can't join if
- Active brain metastases;
- Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;
- Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with...
- Presence of active, known, or suspected autoimmune disease;
- people with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment;
See the full eligibility criteria
- Age ≥ 18 years;
- Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma;
- PD-L1 evaluation and as per standard clinical practice, patients with PD-L1 \ 1% will be treated with anti-PD1 in monotherapy;
- Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and decision by the treating oncologist; ;
- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
- Screening laboratory values must meet the following criteria before starting the treatment:
- WBCs ≥2000/μL
- Neutrophils ≥1500/μL
- Platelets ≥100 x 10³/μL
- Hemoglobin ≥9.0 g/dL
- Serum creatinine of ≤1.5 times the upper normal limits or creatinine clearance \>40 mL/minute
- AST ≤ 3 times the upper normal limits
- ALT ≤ 3 times the upper normal limits
- Total bilirubin ≤1.5 times the upper normal limits (except patients with Gilbert Syndrome who must have total bilirubin \<3.0 mg/dL)
- Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration;
- Patients of reproductive potential, must use adequate contraception methods;
- Signed written consent form;
- Active brain metastases;
- Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;
- Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the...
- Presence of active, known, or suspected autoimmune disease;
- people with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment;
- Participation in any treatment drug or medical device study within 30 days prior to treatment start;
- Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or active C hepatitis or active HIV;
- History of severe hypersensitivity reactions to other monoclonal antibodies;
- Pregnant and breast-feeding women;
- Patients of reproductive who refuse to use effective methods of contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
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 Naples, Italy. 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.