Study on IMA203 vs. Standard Treatment for Previously Treated, Unremovable or Spread Cutaneous Melanoma

Sponsor: Immatics US, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06743126

Provider View

This clinical trial is comparing a new treatment called IMA203 with standard treatments for patients with cutaneous melanoma that cannot be removed or has spread, and who have already received treatment before.

Patient Parameters

Program Overview

This study is testing a new treatment called IMA203 to see if it is safe and effective for patients with cutaneous melanoma that cannot be surgically removed or has spread to other parts of the body. The trial will compare IMA203 to standard treatments chosen by the patient's doctor. Participants will be randomly assigned to receive either the IMA203 treatment or a standard treatment, and their health and response to the treatment will be closely monitored.

Description

Screening:

  • Patients will be checked to see if they meet the study requirements, including a test to see if they have a specific genetic marker (HLA).
  • If eligible, a procedure called leukapheresis may be done to collect white blood cells for making the IMA203 treatment.

Manufacturing:

  • The IMA203 treatment is made from the patient's own white blood cells.

Treatment - Experimental Group:

  • Patients will receive medications (cyclophosphamide and fludarabine) to prepare their body before getting the IMA203 treatment.
  • The IMA203 treatment will be given in the hospital.
  • After receiving IMA203, patients will get a low dose of a medication called IL-2 for up to 10 days.

Treatment - Control Group:

  • Patients will receive a standard treatment chosen by their doctor, which may include medications like nivolumab, pembrolizumab, or chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cutaneous melanoma that cannot be removed or has spread.
  • Have a specific genetic marker (HLA) required for the study.
  • Have good organ function and overall health.
  • Have previously been treated with at least one PD-1 inhibitor for melanoma.
  • If the patient has a BRAF mutation, they should have received BRAF-targeted therapy unless not suitable.
  • Have a life expectancy of more than 6 months.
  • Have measurable cancer according to specific criteria.
  • Women of childbearing age must use effective birth control during and after the study.
  • Men must agree to use birth control or abstain from sex during and after the study.
  • Must have recovered from any side effects of previous treatments before starting the study.

Exclusion Criteria

  • Have a different type of melanoma (mucosal or uveal) or unknown primary melanoma.
  • Have had another cancer in the last 3 years, except for certain skin cancers.
  • Have a serious autoimmune disease unless well controlled.
  • Have a history of certain heart conditions.
  • Have had a stem cell or organ transplant.
  • Have a serious medical condition that could affect participation.
  • Have a history of immune system problems or treatments affecting immune function.
  • Have allergies to study medications.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Be pregnant or breastfeeding.
  • Have received certain treatments or medications recently that could interfere with the study.
  • Have active brain metastases or other specific medical conditions.
  • Be participating in another clinical trial that could interfere with this study.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center15232PittsburghPennsylvania

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