Study of Oral Impact with Anti-PD1 or Anti-PD1 Based Treatments in Adults with Inoperable Locally Advanced or Metastatic Melanoma

What this Trial Is About

Researchers are evaluating the effect of Oral Impact4 on reducing immune-related side effects in patients with inoperable locally advanced or metastatic melanoma. This single-center, prospective study involves 20 patients who will receive Oral Impact4 to support standard anti-PD1 therapies, such as nivolumab alone or combined with ipilimumab or relatlimab. The study compares results to historical data from similar patients who did not receive Oral Impact4. Participants will take Oral Impact4 starting one week before their anti-PD1 treatment. The dosage is two bricks per day for 21 days, followed by one brick per day for 14 days, totaling 35 days. Anti-PD1 treatment according to clinical practice may continue for up to two years. The study focuses on how this nutritional support affects the frequency and severity of severe immune-related adverse events. During the study, patients will be monitored for immune-related side effects for up to 12 months after treatment ends. Researchers will also evaluate prognostic biomarkers from one week before treatment through the end of treatment. Patients will undergo regular assessments including imaging to measure disease status and laboratory tests to ensure safety. Participation lasts throughout treatment and follow-up periods.

Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma