Title: Comparing tebentafusp treatment versus observation in patients with high-risk eye melanoma (uveal melanoma) after initial treatment

3 1 1 1

What is this study about?

This study focuses on uveal melanoma, a type of eye cancer that develops in a part of the eye called the uvea. The research examines the effectiveness of a medication called tebentafusp (KIMMTRAK) given through intravenous infusion after patients have completed their initial treatment with surgery or radiation therapy.

The study aims to determine if using tebentafusp after initial treatment helps prevent the cancer from returning. Patients who participate will either receive tebentafusp treatment or be placed in an observation group. The treatment period may last up to 6 months, during which patients receiving the medication will get infusions of tebentafusp.

The medication being studied, tebentafusp, is designed specifically for patients whose cancer cells have a particular genetic marker called HLA-A*02:01. During the treatment, doctors will monitor patients for any changes in their condition and keep track of how long patients remain free from cancer recurrence. Regular check-ups and medical tests will be performed to ensure patient safety throughout the study period.

1 Initial medical assessment

You have been diagnosed with uveal melanoma (eye melanoma) and have completed either surgery or radiation therapy within the last 11 weeks

Your doctor will assess if you are at high risk based on either stage III cancer or specific genetic test results

Your physical condition will be evaluated using the ECOG scale, which must be 0 or 1 (able to perform daily activities)

2 Screening tests

A test will be performed to confirm if you are HLA-A*02:01 positive

Imaging tests will be conducted to confirm there is no cancer recurrence

Blood tests will check your organ function, including liver, kidney, and blood cell counts

For women of childbearing age, a pregnancy test will be performed

3 Treatment assignment

You will be randomly assigned to one of two groups:

Group 1: Receiving tebentafusp treatment

Group 2: Observation only (no treatment)

4 Treatment period

If assigned to the treatment group, you will receive KIMMTRAK (tebentafusp) through infusion

The medication contains 100 micrograms per 0.5 mL

Treatment will continue until medical assessment determines it should stop

5 Follow-up period

Regular check-ups will monitor for any cancer recurrence

Your overall health status will be tracked

The study will continue until 2032

Who Can Join the Study?

  • Must be 18 years or older
  • Must have primary uveal melanoma (cancer in the eye) that has not spread, excluding iris melanoma, and have completed either surgery or radiation therapy
  • Must be considered high-risk based on either:
    – Stage III cancer, or
    – Specific genetic features of the tumor
  • Must have completed primary treatment within 11 weeks before joining the study
  • Must be HLA-A*02:01 positive (a specific genetic marker)
  • Must have good physical function (ECOG performance status of 0 or 1, meaning able to perform daily activities)
  • Must have adequate organ function, including:
    – Normal kidney function
    – Normal liver function
    – Normal blood cell counts
  • For women who can become pregnant:
    – Must have a negative pregnancy test
    – Must use effective birth control during treatment and for 6 months after
  • For breastfeeding women:
    – Must agree to stop breastfeeding during treatment and for 6 months after
  • Must show no signs of cancer returning on medical imaging within 4 weeks before starting the study
  • Must provide written informed consent to participate in the study

Who Cannot Join the Study?

  • Prior systemic treatment for uveal melanoma (cancer of the eye)
  • History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or cervical cancer
  • Presence of active or untreated brain metastases (cancer spread to the brain)
  • Severe heart conditions including heart failure, unstable angina, or recent heart attack
  • Uncontrolled high blood pressure
  • Severe liver or kidney disease
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • Autoimmune conditions requiring systemic treatment
  • Pregnancy or breastfeeding
  • Known allergy or sensitivity to the study medication or its components
  • Participation in another clinical trial within 30 days before starting this study
  • Mental conditions that could interfere with study compliance
  • Any condition that, in the investigator’s opinion, makes the patient unsuitable for the trial

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Jean Perrin Clermont Ferrand France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Charite Universitaetsmedizin Berlin KöR Berlin Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Cqspmokbr Uqsvuqddyezovq Shyxtyiwk Woluwe-Saint-Lambert Belgium
Uonhjcwvhq Maknkuj Cwfvhf Hdxwbdfkcydiaixcv Hamburg Germany
Udidddvnyakbpwqxudyon Exiji Ayf Essen Germany
Lxxuy Ueoiyuwcbngb Mjxdite Czxlglz (bzvcx Leiden The Netherlands
Ikfdeixf Cizyxh Diaboncvqadfdvbhp L'hospitalet De Llobregat Spain
Sb Vwjevzzxqkjqrcw Urvqnoesot Hqdycveq Dublin Ireland
Ekwnrza Ugipkigjctkl Mqwmnlq Cxsktvq Rrjjqeqqc (mhbeojh Mjq Rotterdam The Netherlands
Ndnhddip Idmndilh Omvmzsmol Izv Mqhmv Samlwgnkstyjcoylvfricxluritp Iyosiqeq Bfkrcksy Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
18.10.2024
France France
Recruiting
18.10.2024
Germany Germany
Recruiting
18.10.2024
Ireland Ireland
Not yet recruiting
18.10.2024
Italy Italy
Not yet recruiting
18.10.2024
Poland Poland
Recruiting
18.10.2024
Spain Spain
Recruiting
18.10.2024
Sweden Sweden
Recruiting
18.10.2024
The Netherlands The Netherlands
Recruiting
18.10.2024

Trial locations

Investigated drugs:

Tebentafusp (also known as IMCgp100) is a bispecific protein drug that helps the immune system recognize and fight cancer cells. It is specifically designed for patients who have a certain genetic marker called HLA-A*02:01 and are diagnosed with uveal melanoma (a type of eye cancer). This medication works by connecting immune cells to cancer cells, enabling the immune system to better target and destroy the cancer. It is given to patients after their initial cancer treatment to help prevent the cancer from coming back.

Observation is the standard approach where patients are regularly monitored by their healthcare team without receiving active treatment. During observation, doctors perform regular check-ups and tests to watch for any signs that the cancer might be returning.

Investigated diseases:

Uveal Melanoma – A rare type of cancer that develops in the uvea, the middle layer of the eye that contains blood vessels and pigment cells. The disease begins when pigment-producing cells called melanocytes in the uvea start growing abnormally and form a tumor. These tumors typically develop in one eye and can affect any part of the uveal tract, including the iris, ciliary body, or choroid. As the tumor grows, it can cause changes in vision or visible changes to the eye’s appearance. The disease can spread from its original location to other parts of the body through the bloodstream.

Trial ID:
2023-510333-28-00
Protocol code:
EORTC 2022-MG
NCT ID:
NCT06246149
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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  • Study on Tebentafusp and Liver Radiotherapy for Patients with Metastatic Uveal Melanoma HLA A*02:01 Positive

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