Study on IMA203 for Patients with Previously Treated Unresectable or Metastatic Skin Melanoma

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What is this study about?

This clinical trial is focused on studying treatments for cutaneous melanoma, a type of skin cancer that can spread to other parts of the body. The study will compare a new treatment called IMA203 with other treatments chosen by doctors. The main goal is to see how effective IMA203 is compared to the other options.

Participants in the study will receive treatments through an intravenous infusion, which means the medicine is given directly into a vein. The study will include several medications, such as pembrolizumab, temozolomide, paclitaxel, nivolumab, ipilimumab, carboplatin, and dacarbazine. These medications are commonly used in cancer treatment and work in different ways to help fight cancer cells. Some participants may receive a placebo, which is a substance with no active medication.

The study will last for a period of time, during which participants will be monitored for their response to the treatment and any side effects. The aim is to gather information on how well the treatments work and how safe they are for patients with previously treated, unresectable, or metastatic cutaneous melanoma.

1 joining the trial

Upon joining the trial, you will be randomly assigned to receive either the new treatment, IMA203, or a treatment chosen by the investigator from a list of approved options. This is to compare the effectiveness of the new treatment against existing ones.

2 treatment administration

If assigned to the IMA203 group, you will receive the medication through an intravenous infusion. This means the medicine will be delivered directly into your bloodstream through a vein.

If assigned to the investigator’s choice group, you may receive one of the following treatments: pembrolizumab, temozolomide, paclitaxel albumin-bound, nivolumab, dacarbazine, carboplatin, ipilimumab, or a combination of nivolumab and relatlimab. These treatments are also administered through intravenous infusion, except for temozolomide, which is taken orally.

3 monitoring and follow-up

Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track the progress of your condition and any side effects you may experience.

The primary goal is to evaluate progression-free survival, which means the length of time during and after the treatment that you live with the disease without it getting worse.

4 end of trial participation

Your participation in the trial will continue until the study ends or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the trial is October 31, 2031.

Who Can Join the Study?

Patients must be 18 years of age or older.
Patients should have an ECOG performance status of 0 to 1, which means they should be fully active or have some symptoms but be able to carry out light work.
Patients must have a confirmed HLA status, which is a specific genetic marker.
Patients need to have adequate kidney, liver, and lung function, as well as acceptable blood clotting and overall organ and bone marrow health.
Patients must have a measurable disease according to RECIST 1.1, which is a standard way to measure how cancer responds to treatment.
Patients must have a confirmed diagnosis of cutaneous melanoma that cannot be removed by surgery or has spread to other parts of the body. They must have experienced disease progression after at least one treatment with a PD-1 inhibitor.
Patients with a BRAF mutation should have been treated with a BRAF-targeted therapy unless it is not suitable due to other medical conditions, previous side effects, or if the patient chooses not to undergo this treatment.
Patients must have recovered from any side effects of previous treatments to a mild level (grade 1 or lower) before starting the trial treatment.

Who Cannot Join the Study?

Patients with any other type of cancer besides cutaneous malignant melanoma cannot participate. Cutaneous malignant melanoma is a type of skin cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of allergic reactions to the study medication or similar drugs cannot participate.
Patients who are unable to provide informed consent cannot participate. Informed consent means understanding the study and agreeing to take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hopital Beaujon	Clichy	France
Utbkimpmft Mmotyqr Cestpj Hgeundmnhrwcxmppo	Hamburg	Germany
Ugdrfiwfiygbsxnrxkugf Enogg Aoj	Essen	Germany
Ujpbrncladdh Mpynkys Cxfiyik Gookgzqqi	Groningen	The Netherlands
Ujssqbcxnd Hbjcdjzx Cvdljqb	Cologne	Germany
Ewiqydz Uadculicdroc Mpjzodt Crxlkeo Repjqszvy (fcsdmiu Mhp	Rotterdam	The Netherlands
Gptejl Uebqvdsfah Fzslnuvwa	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.03.2025
Germany	Recruiting	01.03.2025
The Netherlands	Not yet recruiting	01.03.2025

Trial locations

Investigated drugs:

IMA203 is a new type of treatment being tested for patients with a specific kind of skin cancer called cutaneous melanoma. This treatment is designed to help the body’s immune system recognize and attack cancer cells more effectively. It is being compared to other treatments chosen by doctors to see how well it works and how safe it is for patients who have already tried other treatments but still have cancer that cannot be removed by surgery or has spread to other parts of the body.

Investigated diseases:

Malignant melanoma

Cutaneous Malignant Melanoma – This is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It typically begins as a mole or a dark spot on the skin that changes in size, shape, or color over time. As the disease progresses, the melanoma can grow deeper into the skin and may spread to other parts of the body, including lymph nodes and internal organs. The progression is often marked by changes in the appearance of the skin lesion and the development of new symptoms such as itching or bleeding. Early stages are usually confined to the skin, but advanced stages involve metastasis, where cancer cells spread beyond the original site. Monitoring changes in skin lesions is crucial for understanding the progression of this disease.

Trial ID:

2024-517062-42-00

Protocol code:

IMA203-301

NCT ID:

NCT06743126

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on IMA203 for Patients with Previously Treated Unresectable or Metastatic Skin Melanoma

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