Phase 2 Trial for Metastatic Melanoma Using Cell Therapy with Tumor Infiltrating Lymphocytes and IL-2, with or without Pembrolizumab

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02621021

Provider View

This study is testing a new treatment for metastatic melanoma that uses a patient's own immune cells, grown in a lab, to fight cancer. Researchers are exploring if adding the drug pembrolizumab can make this treatment more effective.

Patient Parameters

Program Overview

This trial is investigating a new approach to treat metastatic melanoma by using a patient's own immune cells, called tumor infiltrating lymphocytes (TIL), which are grown in a lab and then returned to the patient. The study aims to see if adding the drug pembrolizumab to this cell therapy can safely and effectively shrink melanoma tumors in adults aged 18 to 72.

Description

This study involves a treatment called adoptive cell therapy, where a patient's own immune cells (TIL) are taken from their tumor, grown in a lab, and then given back to them to help fight cancer. The treatment is combined with a drug called aldesleukin (IL-2) to boost the immune response. Researchers are testing if adding another drug, pembrolizumab, can enhance the effectiveness of this therapy.

Participants will undergo several steps, including:

  • Screening with physical exams, scans, and blood tests.
  • A procedure to collect white blood cells and a sample of the tumor to grow TIL cells.
  • Hospital stay for treatment, which includes chemotherapy, TIL cell infusion, and possibly pembrolizumab.
  • Recovery period and follow-up visits to monitor health and treatment effects.

The study will enroll up to 53 patients over 3-4 years, with different groups based on previous treatments and eligibility for pembrolizumab. Participants will receive antibiotics and antivirals after treatment to prevent infections and may continue pembrolizumab for additional cycles if assigned.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic melanoma with at least one tumor that can be removed for TIL cell preparation.
  • Be between 18 and 72 years old.
  • Have previously received at least one treatment for metastatic melanoma.
  • Have no more than three small brain tumors that are not causing symptoms and are stable after treatment.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to use birth control during the study and for up to four months after treatment.
  • Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control with appropriate treatments.
  • Women must not be pregnant and must undergo a pregnancy test before starting treatment.
  • Have adequate blood cell counts and organ function as indicated by specific blood tests.
  • Have completed any previous cancer treatments and show disease progression at the time of treatment.
  • Be enrolled in a related study protocol (03-C-0277).

Exclusion Criteria

  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Have primary immunodeficiency disorders.
  • Have active infections or other serious medical conditions requiring treatment.
  • Have a history of major autoimmune diseases or severe allergic reactions to study drugs.
  • Are currently taking systemic steroids or other investigational agents.
  • Have significant heart or lung problems, such as low heart function or lung capacity.
  • Have experienced severe immune-related side effects from previous treatments.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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