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Spots Global Cancer Trial Database for Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma

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Trial Identification

Brief Title: Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma

Official Title: A Phase II Non-Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of Tebentafusp in Melanoma With Molecular Relapsed Disease

Study ID: NCT05315258

Interventions

Tebentafusp

Study Description

Brief Summary: Researchers are trying to find ways to improve the management of people with intermediate or high risk resected cutaneous melanoma or with primary uveal melanoma. This research study is investigating using a new blood test to decide when to give a drug called tebentafusp. Tebentafusp has been used in clinical trials in patients with advanced cutaneous and uveal melanoma. This study is designed to determine if tebentafusp can help patients with cutaneous or uveal melanoma live longer.

Detailed Description: TebeMRD is an unblinded non-randomised, open labelled, safety and efficacy study involving 2 patient cohorts: * A: Cutaneous melanoma with molecular relapsed disease (MRD) * B: Uveal melanoma with MRD Approximately 850 patients (600 cutaneous melanoma, 250 uveal melanoma) will be enrolled from 50 centres to screen for HLA-A\*0201 status and then followed for up to 24 months for MRD at those same centres. Patients identified with MRD will be invited to be treated with tebentafusp at up to 10 treating centres in the UK. Patients in cohorts A and B will receive up to six months of tebentafusp, administered weekly IV, and then will be followed-up for 12 months for molecular and clinical relapse. Patients will be in the pre-screening phase for determination of HLA-A\*0201 status for up to 2 weeks. Those patients who are positive for HLA-A\*0201 will be followed for MRD and will attend the clinical sites for 3 monthly testing for up to 24 months. Patients will leave the study if no molecular relapse is detected during the molecular screening period. When MRD is identified, patients will be evaluated for eligibility to enter the main study at one of up to 10 specialist treatment centres, where patients will enter the screening period for determination of eligibility to start tebentafusp administration within 6 weeks. After a maximum 6 months treatment patients will be followed up for 12 months, or until the study is completed, if this is longer.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom

The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

The Clatterbridge Cancer Centre, Liverpool, , United Kingdom

University College London Hospital, London, , United Kingdom

The Christie Hospital, Manchester, , United Kingdom

Mount Vernon Cancer Centre, Middlesex, , United Kingdom

Churchill Hospital, Oxford University Hospitals NHS Trust, Oxford, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom

Contact Details

Name: Mark Middleton

Affiliation: Consultant Medical Oncologist and Professor of Experimental Cancer Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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