Study on the Effectiveness of L19IL2, L19TNF, or L19IL2/L19TNF with Pembrolizumab for Unresectable Melanoma

Sponsor: Philogen S.p.A.

Sponsor score: 0

ClinicalTrials ID:NCT06284590

This clinical trial is testing new treatments for patients with advanced melanoma that cannot be surgically removed. The study is evaluating the effectiveness of combining different drugs with pembrolizumab, an existing immunotherapy, to see if they can better control the cancer.

Patient Parameters

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Program Overview

The purpose of this study is to find out if using L19IL2, L19TNF, or a combination of both, along with pembrolizumab, can help treat advanced melanoma that cannot be removed by surgery. The study will compare these treatments to previous results of using pembrolizumab alone in similar patients. Researchers want to see if these new combinations can improve outcomes for patients whose cancer has not responded to previous treatments.

Description

This study involves three different treatment groups for patients with advanced melanoma that cannot be surgically removed. Participants will be randomly assigned to one of three groups:

Pembrolizumab with L19IL2
Pembrolizumab with L19TNF
Pembrolizumab with both L19IL2 and L19TNF

The study will start with a two-week screening period, followed by a four-week treatment period where patients receive the assigned combination of drugs. Pembrolizumab will be given every three weeks for up to two years, or until the cancer progresses or side effects become too severe.

The main goal is to see if these treatments can shrink tumors in patients who have not responded to previous anti-PD1 treatments. Researchers will also monitor how long patients live without the cancer getting worse and overall survival rates. Safety and side effects will be closely watched, especially in the first 12 patients in each group.

Patients will be followed for up to three years to gather information on their survival and any progression of the disease. The study aims to provide new insights into treating advanced melanoma with these drug combinations.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have a confirmed diagnosis of advanced melanoma that cannot be surgically removed.
Have previously tried anti-PD1 treatments without success.
Have measurable disease and be a candidate for the study's drug injections.
Women must not be pregnant or breastfeeding and must use effective birth control.
Must provide a tumor sample for analysis.
Have good overall health and organ function.
Must not have active infections like HIV, hepatitis B, or C.
Must have recovered from any previous cancer treatments.
Must be willing to follow the study's procedures and schedule.

Exclusion Criteria

Have more than 10 distant melanoma lesions.
Have certain types of melanoma like uveal or mucosal melanoma.
Women who are pregnant or have a positive pregnancy test.
Have had severe side effects from previous similar treatments.
Have received other cancer treatments recently.
Have active brain metastases or other serious health conditions.
Have a history of severe allergic reactions to the study drugs.
Have active autoimmune diseases requiring treatment.
Have a history of lung disease or current lung issues.
Have any condition that might interfere with the study or its results.

Locations

FACILITY	ZIP	CITY	STATE
Memorial Sloan Kettering Cancer Center	10065	New York	New York

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