Evaluating Oral Impact® with Anti PD-1 Treatment for Advanced Melanoma

An Interventional, Not Pharmacological Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma

This study is testing if Oral Impact® can help people with advanced melanoma have fewer side effects when they start treatment with an immune therapy called nivolumab.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Melanoma Onlus (Academic / other)
• Drugs / interventions: Nivolumab, Ipilimumab, Relatlimab
• Locations: 1 site (Naples)
• Trial ID: NCT06880198 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Oral Impact® in reducing immune-related adverse events in patients with inoperable locally advanced or metastatic melanoma. A total of 20 patients will receive Oral Impact® for a specified duration before starting treatment with nivolumab, an anti-PD-1 therapy. The study will compare outcomes with historical data from similar patients who did not receive Oral Impact®. The goal is to assess whether this intervention can improve patient tolerance to the standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with unresectable stage III or IV cutaneous melanoma and medium-high PD-L1 expression.

Not a fit: Patients with resectable melanoma or those without PD-L1 expression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the safety and tolerability of anti-PD-1 therapy in melanoma patients.

How similar studies have performed: While this approach is novel, similar studies have shown promise in enhancing treatment tolerability in cancer therapies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years;
2. Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma;
3. PD-L1 evaluation and as per standard clinical practice, patients with PD-L1 \< 1% will be treated with anti PD1 based regimen and patients with PD-L1\>1% will be treated with anti-PD1 in monotherapy;
4. 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; ;
5. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
7. Screening laboratory values must meet the following criteria before starting the treatment:

   1. WBCs ≥2000/μL
   2. Neutrophils ≥1500/μL
   3. Platelets ≥100 x 10³/μL
   4. Hemoglobin ≥9.0 g/dL
   5. Serum creatinine of ≤1.5 times the upper normal limits or creatinine clearance \>40 mL/minute
   6. AST ≤ 3 times the upper normal limits
   7. ALT ≤ 3 times the upper normal limits
   8. Total bilirubin ≤1.5 times the upper normal limits (except patients with Gilbert Syndrome who must have total bilirubin \<3.0 mg/dL)
8. Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration;
9. Patients of reproductive potential, must use adequate contraception methods;
10. Signed written consent form;

Exclusion Criteria:

1. Active brain metastases;
2. Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;
3. Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;
4. 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 ability of the patient to receive protocol therapy;
5. Presence of active, known, or suspected autoimmune disease;
6. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment;
7. Participation in any interventional drug or medical device study within 30 days prior to treatment start;
8. 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;
9. History of severe hypersensitivity reactions to other monoclonal antibodies;
10. Pregnant and breast-feeding women;
11. Patients of reproductive who refuse to use effective methods of contraception.

Where this trial is running

Naples

• Istituto Nazionale Tumori IRCCS - Fondazione "G. Pascale" — Naples, Italy (Recruiting)

Study contacts

• Study coordinator: Paolo A. Ascierto

Conditions Melanoma Metastatic; Locally Advanced Melanoma