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21 trials in 41 locations

MoleGazer: A Feasibility Study for Early Detection of Melanoma

Melanoma (skin cancer) frequently develops from existing moles on the skin. Current practice relies on expert dermatologists being able to successfully identify new/changing moles in individuals with multiple moles. Total body photography (TBP-high-quality images of the entire skin) can track and monitor moles over time to detect melanoma.However, TBP is currently used as a visual guide when diagnosing melanoma, requiring visual inspection of each mole sequentially. This process is challenging, time-consuming and inefficient. Artificial [...]

Locations: Churchill Hospital (PI: Rubeta Matin)

NAVIGATE: A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors

This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. [...]

Locations: University College London Hospitals NHS Foundation Trust (UCLH) (PI: Martin Forster), Beatson West of Scotland Cancer Centre (PI: Patricia Roxburgh),

The SCOPE Study: A Phase 2, Multicentre, Open-Label Study of SCIB1 in Patients with Advanced Unresectable Melanoma Receiving Either Nivolumab with Ipilimumab or Pembrolizumab

The purpose of this study is to find out if a new treatment cancer vaccine called SCIB1 can be used safely when added to either nivolumab (Opdivo) with ipilimumab (Yervoy) or pembrolizumab (Keytruda), standard treatments approved for patients with advanced melanoma (skin cancer).The study will also look to see if SCIB1 can increase the likelihood that melanoma patients will respond to either nivolumab with ipilimumab or pembrolizumab, and also if SCIB1 can help to [...]

Locations: Churchill Hospital, Oxford University NHS Trust (PI: Miranda Payne), Weston Park Hospital (PI: Sarah Danson), Velindre University NHS Trust (PI: Satish Kumar), Nottingham University Hospitals NHS Trust (PI: Poulam Patel), Mount Vernon Hospital, East and North Hertfordshire NHS Trust (PI: Heather Shaw)

DELTA-1: A Phase 2, Open-label, Multicentre Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma

DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumour-infiltrating immune cells (lymphocytes; TILs). [...]

Locations: Cambridge University Hospitals NHS Trust (PI: Pippa Corrie)

ARTISTRY-6: A Phase 2, Open-label, Multicentre, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy

This study observes the anti-tumour activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy [...]

Locations: The Christie NHS Foundation Trust (PI: Avinash Gupta), Oxford University Hospitals NHS Foundation Trust (PI: Prof. Mark Middleton)

RELATIVITY-098: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

The purpose of this study is to assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma. [...]

Locations: Nottingham University Hospitals NHS Trust (PI: Poulam Patel), The Beatson West of Scotland Cancer Centre (PI: Yun Yi Tan), Churchill Hospital (PI: Miranda Payne)

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

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 [...]

Locations: Churchill Hospital (PI: Mark Middleton)

MITRE: An Observational Study to Evaluate the Microbiome as a Biomarker of Efficacy and Toxicity in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy

This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer. [...]

Locations: Weston Park Hospital (PI: Sarah Danson), Addenbrookes, Cambridge University Hospitals NHS Trust (PI: Pippa Corrie), Bristol Haematology and Oncology Centre (PI: Helen Winter), Royal Cornwall Hospital (PI: Toby Talbot), Somerset NHS Foundation Trust (PI: Clare Barlow), Norfolk and Norwich University Hospitals (PI: Jenny Nobes), Royal United Hospital Bath (PI: Tania Tillett), University Hospital Southampton (PI: Matthew Wheater), Royal Bournemouth Hospital (PI: Tom Geldart), Leicester Royal Infirmary (PI: Guy Faust), Western General Hospital (PI: Ewan Brown)

THETIS (ATX-ME-001): An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Metastatic or Recurrent Melanoma

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma. [...]

Locations: University College London Hospital (UCLH) (PI: Heather Shaw), Cambridge University Hospitals NHS Foundation Trust (PI: Brent O'Carrigan), University Hospital Southampton (PI: Ioannis Karydis), The Royal Marsden Hospital (LONDON) (PI: Samra Turajlic), Guys and St Thomas's NHS Foundation Trust (PI: Rebecca Kristeleit), Freeman Hospital (PI: Ruth Plummer), The Christie NHS Foundation Trust (PI: Fiona Thistlethwaite)

IGNYTE: An Open-Label, Multicentre, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumours, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.THIS TRIAL IS CURRENTLY ONTO PHASE 2. [...]

Locations: University Hospital Southampton (PI: Ioannis Karydis), St James's University Hospital (PI: Adel Samson), The Royal Marsden Hospital (LONDON) (PI: Kevin Harrington), Churchill Hospital (PI: Mark Middleton), The Clatterbridge Cancer Centre NHS Foundation Trust (PI: Joseph Sacco), Beatson West of Scotland Cancer Center (PI: Patricia Roxburgh)

DETECTION: Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION

Having surgery to remove the melanoma will cure the majority of patients with early stage disease. However, a small percentage of these patients will go on to develop further disease, which may spread to other places in their body.Currently, patients who have been cured of melanoma will have appointments in clinic to check that further disease has not developed or returned and some may also receive regular scans.The trial team has developed a blood [...]

Locations: Churchill Hospital (PI: Miranda Payne), Addenbrookes Hospital (PI: Brent O'Carrigan), Nottingham City Hospital (PI: Hester Franks), The Christie NHS Foundation Trust (PI: Paul Lorigan), The Beatson West of Scotland Cancer Centre (PI: Ashita Waterston)

DANTE: Duration of Anti-PD1 therapy for melanoma

This trial aims to determine whether anti-PD1 monotherapy to treat advanced melanoma can be stopped after 1 year, rather than the current standard practice (i.e. continuing to treat until disease progression/unacceptable toxicity, or for at least 2 years), and achieve and maintain as good an outcome (in terms of the cancer coming back). The hypothesis is that continuing treatment beyond 1 year is unnecessary, as there is no biological evidence that justifies continuous therapy; [...]

Locations: This trial is no longer recruiting new patients

INITIUM STUDY: Efficacy and Safety of UV1 Vaccination in Combination With Nivolumab and Ipilimumab as First Line Treatment of Patients With Unresectable or Metastatic Melanoma

This is a randomized, open label study to investigate efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as first line treatment of adult patients with histologically confirmed unresectable metastatic melanoma. UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. [...]

Locations: The Christie NHS Foundation Trust (PI: Paul Lorigan)

PECan: Measurement of PDL1 Expression in Cancer to Monitor Treatment Response.

Measurement of PDL1 expression in cancer to monitor treatment response.A prospective single centre non-randomised exploratory observational study.To determine the baseline level and variability within and between patients and tumour types of PDL1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using [99mTc]-anti-PDL1 SPECT and immunohistochemistry. [...]

Locations: Guy's and St Thomas' NHS Trust (PI: Professor Gary Cook)

MISST: Melanoma Immunomodulation and Immune Responses of the Skin Study: A Translational Science Research Protocol

In this study we aim to investigate the nature of immune responses in human skin and in melanoma and to utilise these insights in order to explore potential novel treatment and clinical management avenues to benefit patients. T cells, B cells and other inflammatory and cytotoxic cells, such as monocytes and macrophages, found in the circulation and the tumour lesions of patients with melanoma will be investigated and compared with those from healthy volunteers.We [...]

Locations: Guy's and St Thomas' NHS Trust (PI: Katie Lacy)

MelMarT-II: Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in [...]

Locations: Royal Cornwall Hospital (PI: Polly King), Cambridge University Hospitals NHS Trust (PI: Amit Roshan and Amer Durrani), Guys and St Thomas' NHS Foundation Trust (PI: Jenny Geh), North Bristol NHS Trust (PI: Ewan Wilson), Norfolk and Norwich University Hospital (PI: Prof Marc Moncrieff), Hull University Teaching Hospitals NHS Trust (PI: Paolo Matteucci), Oxford University Hospitals NHS Foundation Trust (PI: Oliver Cassell), Nottingham University Hospitals NHS Trust (PI: Jonathan Pollock), Queen Victoria Hospital NHS Foundation Trust (PI: Siva Kumar), The Royal Marsden NHS Foundation Trust (PI: Myles Smith), St Helen's & Knowsley Hospitals Trust (PI: Prof Rowan Pritchard Jones), St George's University Hospitals NHS Foundation Trust (PI: Joy Odili), The Leeds Teaching Hospitals NHS Trust (PI: Howard Peach), Mid and South Essex NHS Trust (PI: Professor Peter Dziewulski), South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital (PI: Oliver Bassett)

BNT111-01: Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

This is an open-label, randomised, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-PD-1-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients in single agent calibrator arms, who experience disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent. [...]

Locations: Royal Cornwall Hospital (PI: Toby Talbot)

TEBENTAFUSP: Tebentafusp Managed Access Program for Metastatic Uveal Melanoma

Uveal melanoma (UM) is a rare and highly malignant neoplasm affecting the vascular layers of the eye (iris, ciliary body, or choroid). Once patients develop metastases, primarily to the liver, the prognosis is poor with a median survival of less than 12 months. There are no effective treatments for metastatic UM that extend survival, and there is no proven standard of care. Enrollment in clinical trials is the treatment option recommended by the UK [...]

Locations: The Beatson West of Scotland Cancer Centre (PI: Yun Yi Tan), Norfolk and Norwich University Hospital (PI: Jenny Nobes), Belfast City Hospital (PI: Judith Carser), The Royal Marsden (LONDON) (PI: Andrew Furness), Royal Preston Hospital (PI: Kellati Prasad), University Hospital Birmingham (PI: Leila Khoja), Nottingham City Hospital (PI: Ankit Rao), Poole Hospital (PI: Rachel Plant), Cheltenham General Hospital (PI: David Farrugia), East and North Hertfordshire NHS Trust (PI: Heather Shaw), Castle Hill Hospital (PI: Dulani Ranataunge), Bristol Haematology and Oncology Centre (PI: Hannah Taylor), The Christie NHS Foundation Trust (PI: Paul Lorigan), The Freeman Hospital (PI: Ruth Plummer), Royal Cornwall Hospital (PI: Toby Talbot), The Clatterbridge Cancer Centre - LIVERPOOL (PI: Joseph Sacco)

IMP-MEL: Testing IMM60 in combination with pembrolizumab in melanoma and non-small cell lung cancer

The trial is a first-in-human study called the IMP-MEL trial and is sponsored by the University of Oxford; the information we get from this trial may help us to improve the future treatment of patients with melanoma and non-small cell lung cancer. The experimental drug, called IMM60, has not been given to patients before.This trial will aim to:• Establish the safe dose of IMM60• Establish that the safe dose of IMM60 can be safely [...]

Locations: John Radcliffe Hospital (PI: Prof. Mark Middleton)

OOB: The Liverpool Ocular Oncology Biobank

The Liverpool Ocular Oncology Biobank (OOB) works closely with local and regional hospitals to collect and store ocular biosamples, blood and associated clinical data from consenting patients for use in research relating to eye cancers and other eye diseases. By doing this, the biobank can build a valuable collection that will be used by research groups across the world to address key basic and clinical research questions necessary to improve the healthcare of future [...]

Locations: The Liverpool Ocular Oncology Centre (PI: Dr Helen Kalirai (Biobank Custodian))

MAAM Study: The use of Microwave Ablation in the treatment of advanced melanoma with cutaneous metastases. An observational study using Emblation's microwave based treatment system SwiftTM

This is a pilot study to establish if MWA can successfully treat metastatic melanoma deposits using the Swift device manufactured by Emblation. As a control group, they will also test whether MWA can treat other skin lesions where standard surgical management is not recommended (including other skin cancer metastases, viral warts). The hypothesis is that precise directed delivery of microwave energy onto a melanoma deposit will lead to its destruction. In this biomarker [...]

Locations: University Hospital Southampton (PI: Danny O'Driscoll (study coordinator))