Melanoma TrialFinder

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Trial details

TEBENTAFUSP: Tebentafusp Managed Access Program for Metastatic Uveal Melanoma

Who can take part?

A managed access program can be set up by a drug company to allow patients to have access to treatments when clinical trial results for a drug have been positive. The company has set up this program while it is waiting for the treatment to be approved as a standard treatment for metastatic uveal melanoma, so that it can prescribed by doctors as part of standard of care.

The tebentafusp access program must be approved within the hospital before patients are able to receive treatment. A number of hospitals are already open across the UK, and your doctor may be able to refer you to have treatment there. New hospitals can request access to the treatment for their patients who fit the eligibility criteria, therefore, this can also be discussed with your doctor at your local hospital.

Please note - the below list is not exhaustive, there may be other factors affecting who can take part and you need to talk to your doctor about joining a managed access program.

There are ( eligibility criteria ) about who can have access to these programs, such as the type of cancer, stage of the disease, and previous treatments; you will need to discuss these in detail with your doctor.

You may be able to take part in this program if:

• you are 18 years of age or over

• you HAVE stage 4 metastatic uveal melanoma

About this trial/study

Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the body’s natural defence ( immune system ), known as immunotherapy.

Some melanomas can avoid being seen or detected by the patient's own immune system, so that they can’t be attacked or killed. immunotherapy works by stimulating the immune system to work against the melanoma by turning on or turning off certain signals in the immune system, to allow the body to find, attack and kill the melanoma cells.

Tebentafusp is a drug treatment that has been tested in clinical trials and has been shown to target a certain protein found in melanoma cells. Tebentafusp helps the immune system to find, attack and kill the melanoma cells more effectively.

Taking part in the trial/study

> Screening Period

This may last for up to 4 weeks and you will need to visit the hospital at least once during this time. The purpose of the screening period is to make sure that you are a good fit for this program and that this program is also a good fit for you.

If you meet the eligibility criteria and are accepted onto the program, you will be given treatment with tebentafusp for as long as your doctors think you are getting benefit from it.

After providing written informed consent, you will have certain tests, examinations, and procedures during the program.

> Treatment Period

Patients will receive tebentafusp as an intravenous infusion (e.g., a slow injection into a vein) over approximately 15 minutes in a hospital or clinic.

For the first 3 doses of tebentafusp all patients will need to stay overnight at the hospital, on Day 1, Day 8 and on Day 15 of the program. This is so that the medical team can closely monitor the patient’s health and check for any reactions or side effects that may be experienced after receiving tebentafusp for the first time.

On Day 1 of the program, patients will receive a 20-microgram dose of tebentafusp and on Day 8, they will receive a 30-microgram dose.

On Day 15, patients will receive a 68-microgram dose of tebentafusp.

If the patient copes with these doses well, they will continue to receive a 68-microgram dose of tebentafusp once every week as an intravenous infusion (e.g., a slow injection into a vein) in a hospital or clinic.

Patients can continue the treatment for the length of time tebentafusp is controlling the melanoma, unless they develop signs of any harmful side effects, or the doctors think the patient is no longer benefiting from treatment.

If tebentafusp gets approval to be paid for by the NHS, the managed access program will close. Patients that are on the program will then continue to receive tebentafusp as standard of care from their local hospital. There will be no impact on the drug treatment during this change over.

Once treatment with tebentafusp on the managed access program has ended, patients may be asked to come for follow-up appointments. This can be so that a physical examination can be carried out, blood tests can be taken, or patients may be asked to answer a questionnaire; for example, about their daily life, or any possible side effects experienced from the tebentafusp treatment.

Please note; the length of the follow-up period for this program will not affect you from being treated on another program (with a different drug) in the future.

Sponsor

Immunocore

Locations

Belfast City Hospital, 10 Jubilee Road, BT9 7JL
Bristol Haematology and Oncology Centre, 22 Horfield Rd, South West, BS2 8ED
Castle Hill Hospital, Cottingham, Yorkshire and The Humber, HU16 5JQ
Cheltenham General Hospital, Sandford Road, CHELTENHAM, GL53 7AN
East and North Hertfordshire NHS Trust, Mount Vernon Hospital, Northwood, London, HA62RN
Musgrove Park Hospital, Somerset NHS Foundation Trust, TAUNTON, TA1 5DA
Norfolk and Norwich University Hospital, Colney Lane, NORWICH, NR4 7UY
Nottingham City Hospital, Hucknall Rd, NOTTINGHAM, NG5 1PB
Poole Hospital, University Hospitals Dorset NHS Foundation Trust, Longfleet Road, POOLE, BH15 2JB
Royal Cornwall Hospital, Treliske, TRURO, TR1 3LJ
Royal Preston Hospital, Sharoe Green Lane, North West, PR2 9HT
The Beatson West of Scotland Cancer Centre, 1053 Great Western Road, GLASGOW, G12 0YN
The Christie NHS Foundation Trust, 550 Wilmslow Road, MANCHESTER, M20 4BX
The Clatterbridge Cancer Centre - LIVERPOOL, 65 Pembroke Place, North West, L7 8YA
The Freeman Hospital, Freeman Road, NEWCASTLE UPON TYNE, NE7 7DN,
The Royal Marsden (LONDON), 203 Fulham Rd, Chelsea, London, SW3 6JJ
University Hospital Birmingham, QUEEN ELIZABETH HOSPITAL, West Midlands, B15 2TH
William Harvey Hospital, East Kent Hospitals University NHS Foundation Trust, ASHFORD, TN24 0LZ

Key information

Recruitment Status
Recruiting

Start Date
01/04/2021

End Date
31/03/2023

Phase
N/A

Condition
Metastatic Melanoma, Advanced Melanoma, Uveal Melanoma

Age
Over 18 years

Stage
4

Last Updated
21/12/2022