Study Details

Open

Comparing IMA203 to physician's choice of treatment for metastatic cutaneous melanoma

The purpose of this research is to find out whether the investigational drug IMA203 is an effective and safe treatment for patients with cutaneous melanoma (i.e. skin cancer) that is growing or has returned after prior standard treatment.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the study team to determine if you are eligible for the study. You will have an exam, labs drawn, tests done, and provide tumor samples. You may need to undergo a tumor biopsy if you do not have tissue from a prior biopsy to provide for testing. If you are eligible, you will have cells collected to manufacture the study treatment. You will be randomized to receive either the study treatment or your physician's choice of treatment. You will receive your assigned treatment and will have labs, tests, and imaging done during this time. Once you have completed treatment, you will be followed by the study team to see how well you have responded to treatment. During this time, various labs, tests and imaging will be done to look for side effects and determine whether your cancer has responded to therapy.

In-person visits:
23 for treatment, number of visits for follow-up varies

Phone or online visits:
Dependent on if you receive study drug or physician's choice of treatment

Total length of participation:
Approximately 5 years, may be longer depending on your response to study treatment. If treated with IMA203-301, you will be monitored for 15 years

Looking for Specific Volunteers

Able to participate:

Have diagnosis of cutaneous melanoma that cannot be resected or is metastatic
Have HLA type as required per study
Have adequate organ and lab values per protocol
Have measurable disease
Must not have more than mild side effects related to your prior treatments

Not eligible if:

Have primary mucosal or uveal melanoma
History of other malignancies within the past 3 years (except for treated basal or squamous cell carcinoma)
Have a serious autoimmune disease
Have brain metastases or leptomeningeal metastases
Have ongoing, active infection

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Immunotherapy Team
UNCImmunotherapy@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Stergios Moschos
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Melanoma)

IRB Number

24-2682