Study on the Safety and Effectiveness of IOV-3001 in Adults with Advanced Melanoma Receiving Lifileucel

Sponsor: Iovance Biotherapeutics, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT06940739

Provider View

This clinical trial is testing a new treatment, IOV-3001, in adults with advanced melanoma that cannot be surgically removed or has spread to other parts of the body. The study aims to determine if IOV-3001 is safe and effective when used with another treatment called Lifileucel.

Patient Parameters

Program Overview

This study is exploring a new treatment called IOV-3001, which is a modified protein designed to help the immune system fight melanoma, a type of skin cancer. The study is open to adults who have melanoma that cannot be removed by surgery or has spread to other areas. Participants will receive IOV-3001 either before or after another treatment called Lifileucel, which is used to help the body attack cancer cells. The main goals are to see if IOV-3001 is safe and if it can help improve treatment outcomes for people with advanced melanoma.

Description

This is the first study to test IOV-3001 in humans. IOV-3001 is a special protein that combines a modified form of a drug called aldesleukin with an antibody. The study has two parts. In the first part, participants will receive IOV-3001 before starting the Lifileucel treatment. In the second part, participants will receive IOV-3001 after Lifileucel instead of aldesleukin. The study aims to find out if this new approach is safe and can help treat advanced melanoma.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have melanoma that cannot be surgically removed or has spread to other parts of the body.
  • Have melanoma that is not of eye origin and has worsened during or shortly after treatment with certain immune therapies. If the melanoma has a specific mutation (BRAF V600), the participant must have tried or refused other specific treatments.
  • For certain participants with eye melanoma, a specific treatment must have been tried or refused if available.
  • Must be in good overall health with a life expectancy of more than 6 months.
  • For some participants, must have at least one measurable tumor after surgery for Lifileucel treatment.
  • Must have recovered from any side effects of previous cancer treatments.

Exclusion Criteria

  • Have untreated brain cancer that is causing symptoms.
  • Have a high risk of infections, seizures, blood clotting issues, or other serious health problems.
  • Have active eye inflammation that needs treatment.
  • Have a primary immune deficiency or conditions like AIDS.
  • Have allergies to any part of the study treatment.
  • Have had another type of cancer in the past 3 years.
  • Need to take high doses of steroids daily.
  • Have had an organ transplant or certain cell therapies in the past 20 years.

Locations

FACILITYZIPCITYSTATE
Sarah Cannon Research Institute37203NashvilleTennessee

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