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Clinical trials

A clinical trial is something that can be offered at any part in the bladder cancer journey, from initial suspected diagnosis, through investigations and different treatment, and in later follow-ups, or at the end of life.

A clinical trial can be offered at any stage in the bladder cancer journey, from initial diagnosis, through investigations and different treatments to later follow-ups or even the end of life.

There are a number of clinical trials in bladder cancer. These usually compare a new treatment which has the potential of working better or with less side effects, with what is used as the “gold-standard”.

Different trials are available in different hospitals. This is because of either the complexity of the trial or because of the type of treatment or test involved. For example, studies of surgery or radiotherapy may only be open at the particular hospital or cancer centres where the operation or the radiotherapy takes place. All studies have particular tick boxes to confirm whether this study is the correct one for you and your cancer. It may be that you and your type of bladder cancer do not match the eligibility criteria (or check list) for the study.

You should ask your doctor if you are suitable for a clinical trial. It is always helpful to take information with you for any trials that your doctor may not be familiar with. If the study is open elsewhere in the UK and it looks as though you may be eligible for this (and are prepared to travel), you could ask your doctor to refer you.

 

SIGN UP

If you have been affected by bladder cancer and would like to take part in research to improve services, please complete our sign-up form and we'll be in touch with opportunities to take part in various studies.

You can find a full list of open clinical bladder cancer trials in the UK below.

For non-UK trials, please go here.

Current Open Bladder Cancer Trials

 

Suspected Bladder Cancer

UROX BIOMARKER

This trial will need a urine sample from participants who are under investigation for possible bladder cancer and are due to undergo a standard-of-care investigative cystoscopy and biopsy. This study tests whether the UroX biomarker can be detected in urine samples and therefore be a way of diagnosing patients. Both healthy volunteers and bladder cancer participants are needed. 

East and North Hertfordshire NHS Trust

ClinicalTrials.gov ID: NCT03973307

 

Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.

The aim of the study is to assess the feasibility of genomic and epigenetic analysis of rectal mucus to detect non-colorectal cancers of the aero- digestive tract using samples collected by the OriCol™ Sampling Device. The primary objective of the study is to assess whether significant changes in DNA mutation and methylation associated with Non-colorectal cancers of the Aerodigestive Tract (NCRCADT) can be detected in rectal mucus as shed cells and cell-free DNA (cfDNA) pass through the gut and theoretically can be collected from rectal mucus. Secondary objectives will assess the participant acceptability of the OriCol™ Sampling Device for Upper GI and Lung Pathology as well as contributing to a genomic library collating information about rectal mucus

Royal Devon & Exeter NHS Foundation Trust, Exeter

ClinicalTrials.gov ID:  NCT05102110

 

Urinary tract squamous cell carcinoma (UTSCC)

AURORA

This trial is for people with urinary tract squamous cell carcinoma (UTSCC). People participating in this trial will receive an immunotherapy called atezolizumab. This study is investigating whether atezolizumab is tolerable, safe and will help prolong the life of people with urinary tract squamous cell carcinoma.

Locations: University Hospital Southampton, University College London Hospital, James Cook Hospital Middlesborough, Western General Hospital Edinburgh, Beatson West of Scotland Cancer Centre Glasgow, Royal Preston Hospital, Nottingham, Velindre (Cardiff), The Christie Hospital Manchester, Clatterbridge Hospital Liverpool, Royal Marsden Hospital

ClinicalTrials.gov ID: NCT05038657

 

Non-Muscle-Invasive Bladder Cancer (NMIBC)

KEYNOTE-676

This trial examines the effectiveness and safety of combining pembrolizumab, a cancer immunotherapy, with BCG therapy in treating high-risk non-muscle invasive bladder cancer. It targets patients who either have persistent or recurrent cancer after BCG treatment or are new to BCG therapy. The study aims to determine if the combined treatment is more effective than BCG alone in achieving a complete response and extending the time without cancer symptoms.

Locations: Raigmore Hospital, Inverness, Highland, IV2 3UJ; St Bartholomew's Hospital, London, London, EC1A 7BE; St Georges University Hospitals NHS Foundation Trust, London, London, SW17 0QT

ClinicalTrials.gov ID: NCT03711032

 

DETERMINE

This clinical trial is investigating whether the combination of trastuzumab and pertuzumab can be effective in treating types of cancers with HER2 amplification or mutations. Patients eligible for this trial need to high-risk non-muscle invasive bladder cancer that shows changes in the HER2 gene. They should not have received BCG before or should have stopped this treatment more than three years ago. Before joining the trial, any visible bladder tumours must be completely removed, and their urine tests should not show cancer cells if they do not have carcinoma in situ (CIS). HER2 amplification or mutations are changes in the HER2 gene that cause too much of the HER2 protein to be made or change how it works. This protein helps cells grow, and when there is too much or it is faulty, it can cause cells to grow uncontrollably, leading to cancer. Participants will receive the drugs until disease progression or unacceptable side effects occur, with follow-up visits every three months for two years after treatment ends.

Belfast City Hospital, University Hospital Birmingham, Addenbrooke's Hospital in Cambridge, Western General Hospital in Edinburgh, The Beatson Hospital in Glasgow, Leicester Royal Infirmary, University College London Hospital, Guy's Hospital in London, The Christie Hospital in Manchester, Great North Children's Hospital and Freeman Hospital in Newcastle, and Churchill Hospital and John Radcliffe Hospital in Oxford.

ClinicalTrials.gov ID: NCT05786716

 

DURANCE

The DURANCE trial is a study looking at the combination of durvalumab, an immune checkpoint inhibitor, with a novel cancer vaccine (S-488210/S-488211) in people with non-muscle invasive bladder cancer who are unresponsive to or intolerant of BCG therapy. This research aims to determine the safety and effectiveness of this combination treatment, administered over a period of up to 24 weeks. People receive durvalumab intravenously every four weeks and the vaccine through injections, beginning a day after the first durvalumab dose. The study includes an initial evaluation at 12 weeks with a cystoscopy to decide if people should continue based on their response to the treatment.

Locations: Guy's and St Thomas' NHS Foundation Trust, London; The Royal Marsden NHS Foundation Trust, London; University College London Hospital NHS Foundation Trust, London; University Hospital Southampton NHS Foundation Trust, Southampton

ClinicalTrials.gov ID: NCT04106115

 

SunRISe-1

This study is for people with high-risk Non-Muscle Invasive Bladder Cancer. TAR-200 is a pretzel-shaped drug delivery system inserted into the bladder  - it is an investigational product that is comprised of a drug (Cetrelimab). This study consists of 3 periods: screening phase (up to 42 days); treatment phase (up to 2 years); follow-up phase (up to 5 years). The total duration of study is up to 6 years and 7 months.

NHS Greater Glasgow and Clyde

ClinicalTrials.gov Identifier: NCT04640623

 

SunRISe-3

TAR-200, a pretzel-shaped drug delivery system, releases chemotherapy directly into the bladder over time, and in this clinical trial, its effectiveness is being compared with that of cetrelimab combined with TAR-200, TAR-200 alone, and Bacillus Calmette-Guérin (BCG) in treating high-risk non-muscle invasive bladder cancer in patients who have not previously received BCG therapy. The study aims to measure event-free survival and includes a screening phase, treatment phase, and follow-up phase, lasting up to five years and two months.

Western General Hospital in Edinburgh (EH4 2XU), St Bartholomews Hospital in London (EC1A 7BE), The Royal Marsden NHS Trust in London (SW3 6JJ), Charing Cross Hospital in London (W6 8RF), Derriford Hospital in Plymouth (PL6 8DH), Scunthorpe General Hospital in Scunthorpe (DN15 7BH), Sheffield Teaching Hospitals NHS Foundation Trust in Sheffield (S10 2JF), Lister Hospital in Stevenage (SG1 4AB), and Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital in Truro (TR1 3LJ).

ClinicalTrials.gov Identifier: NCT05714202

 

SunRISe-5

This clinical trial is comparing the effectiveness of TAR-200 (a pretzel-shaped drug delivery system designed to release chemotherapy directly into the bladder over an extended period to treat bladder cancer) with intravesical chemotherapy in patients with high-risk non-muscle-invasive bladder cancer who have experienced recurrence after BCG therapy and are either unable or unwilling to undergo radical cystectomy. The study aims to measure disease-free survival among these patients. It is a Phase 3, randomised, open-label trial, meaning it is in an advanced stage of testing, participants are randomly assigned to different treatment groups, and both the researchers and participants know which treatment is being administered.

St Bartholomews Hospital in London (EC1A 7BE), Salford Royal Hospital in Salford (M6 8HD), and Lister Hospital in Stevenage (SG1 4AB)

ClinicalTrials.gov Identifier: NCT06211764

 

EV-104

This clinical trial is testing a new drug called enfortumab vedotin for people with non-muscle invasive bladder cancer. The drug is administered directly into the bladder through a catheter to see if it can effectively treat the cancer. Researchers will also monitor the side effects to ensure the drug is safe for patients. The goal is to find the most effective dose that causes the fewest side effects in part one of the study, and then use that dose in part two to further evaluate its effectiveness.

Location: London, EC1A 7BE

ClinicalTrials.gov ID: NCT05014139

 

Muscle-invasive, advanced or metastatic bladder cancer

DISCUS

This study is for people with locally advanced or metastatic urothelial cancer. It is a randomised phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy before maintenance avelumab immunotherapy.

Queen Mary University of London, Western General Hospital Edinburgh

Clinicaltrialsregister.eu: 2021-001975-17

 

IGNYTE

This study looks at the drug RP1 alone and then RP1 with nivolumab. This trial needs participants with advanced and/or refractory solid tumours. This trial will determine the drug's maximum tolerated and recommended dose. It is for a range of cancers and includes bladder cancer. 

University of Leeds Teaching Hospital,  Oxford University Hospitals NHS Trust,  Beatson West of Scotland Cancer Center Glasgow,  The Clatterbridge Cancer Centre NHS Foundation Trust Bebington,  Royal Marsden Hospital London,  Southampton General Hospital

ClinicalTrials.gov ID: NCT03767348

 

MORPHEUS-UC

This study is for patients with advanced or metastatic bladder cancer whose cancer has worsened during or after chemotherapy. Participants will receive a drug called atezolizumab and may also receive one of these additional drugs: enfortumab vedotin, niraparib, Hu5F9-G4, tiragolumab, sacituzumab govitecan, cisplatin, gemcitabine, or tocilizumab. The goal is to see if these combinations can help treat their cancer.

Barts and The London,  Churchill Hospital Oxford,  Royal Marsden NHS Foundation Trust Sutton

ClinicalTrials.gov ID: NCT03869190

 

MOMENTUM

This registry helps implement the MRI-guided Linear Accelerator radiation therapy system to improve patients' survival, local and regional tumour control and quality of life.

London, Manchester

ClinicalTrials.gov ID: NCT04075305

 

A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.

Leicester Royal Infirmary

ClinicalTrials.gov ID:  NCT04104776

 

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

Evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors. The main goals of this study are to:
1. Find the recommended dose of BT5528 that can be given safely to participants alone and in combination with nivolumab
2. Learn more about the side effects of BT5528
3. Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer.
4. Learn more about BT5528 therapy alone and in combination with nivolumab

Cambridge University Hospitals NHS Foundation Trust,  St James's University Hospital, Leeds,  Sarah Cannon Research Institute UK, London,  The Christie NHS Foundation Trust, Manchester,  Sir Bobby Robson Cancer Trials Research Centre,  Newcastle Upon Tyne

ClinicalTrials.gov ID:  NCT04180371

 

KEYNOTE-992

This study is for people who have muscle-invasive bladder cancer. Patients will receive chemoradiotherapy and might also receive a drug called pembrolizumab. This study looks at how well pembrolizumab works with chemoradiotherapy in people with bladder cancer.

South Devon Healthcare Foundation Trust

ClinicalTrials.gov ID: NCT04241185

 

A Study of SGN-B6A in Advanced Solid Tumors

This trial will look at a drug called SGN-B6A to determine whether it is safe for people with solid tumours. It will study SGN-B6A to find out what its side effects are. It will also study whether SGN-B6A works to treat solid tumours.

The Royal Marsden Hospital Surrey

ClinicalTrials.gov ID: NCT04389632

 

Study DRUG BT8009 in Subjects With Nectin-4 Expressing Advanced Solid Tumor Malignancies

Evaluating a drug called BT8009 alone and in combination with pembrolizumab in participants with advanced solid tumours associated with Nectin-4 expression or in participants with advanced solid tumour having kidney problems. The main goals of this study are to:
1. Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with pembrolizumab
2. Learn more about the side effects and effectiveness of BT8009 alone and in combination with pembrolizumab
3. Learn more about BT8009 alone and in combination with pembrolizumab
4. Learn more about BT8009 alone in patients with renal insufficiency

Sarah Cannon Research Institute UK, London,  The Christie NHS Foundation Trust, Manchester

ClinicalTrials.gov ID:  NCT04561362

 

Neoadjuvant Immune Checkpoint Inhibitor Treatment in Urothelial Cancer (ABACUS-2)

See if the drug atezolizumab can reduce the size of tumours in patients with types of urothelial cancer before surgery. Atezolizumab is designed to stop a protein called PD-L1 (programmed death-ligand 1) being expressed on the cancer, allowing the immune system to recognise the tumour cells as foreign bodies and attack them. Atezolizumab has been shown to have activity in urothelial cancer which has spread.

Barts and London Hospital NHS Trust, London,

ClinicalTrials.gov ID:  NCT04624399

 

AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Research Site, Cambridge,  Manchester,  Oxford,  Sutton

ClinicalTrials.gov Identifier:  NCT04644068

 

IMVIGOR011

This study is for people with high-risk muscle-invasive bladder cancer who have had a cystectomy. Patients will be followed up closely after their cystectomy and may receive the immunotherapy atezolizumab. This study is looking to see if atezolizumab can improve disease-free survival.

Belfast City Hospital,  Addenbrookes Hospital,  Western General Hospital Edinburgh,  St James Hospital,  Barts Hospital, University College London NHS Foundation Trust,  Derriford Hospital,  Royal Preston Hospital,  Weston Park Hospital,  Southampton University Hospitals NHS Trust,  Royal Marsden Hospital (Sutton).

ClinicalTrials.gov ID: NCT04660344

 

A Study of Disitamab Vedotin Alone and With Pembrolizumab in Urothelial Cancer That Expresses HER2

This study aims to determine if a drug called disitamab vedotin, alone or with pembrolizumab, can effectively treat a type of bladder cancer called HER2-expressing urothelial cancer. The study will also assess the safety of the drug for participants. The participants in this study will have cancer that has either spread nearby and cannot be removed by surgery or has spread to other parts of the body. Additionally, the study will examine what side effects occur when participants receive the drug. HER2-expressing urothelial cancer is a type of bladder cancer where the cancer cells have high levels of a protein called HER2 on their surface. This protein helps the cancer cells grow and spread more quickly. Testing positive for HER2 means that the cancer might respond to treatments that specifically target this protein.

Barts Health NHS Trust Saint Bartholomews Hospital, London

ClinicalTrials.gov ID:  NCT04879329

 

TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (SunRISe-4)

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

Barts Health NHS Trust, London

ClinicalTrials.gov ID:  NCT04919512

 

VOLGA

A study to determine the efficacy and safety of durvalumab in combination with tremelimumab and enfortumab vedotin or durvalumab in combination with enfortumab vedotin in people ineligible for chemotherapy undergoing radical cystectomy for muscle-invasive bladder cancer

Research Sites: Blackburn BB2 3HH, Bristol BS2 8ED, Gillingham ME7 5NY, Glasgow G12 0XH, London EC1A 7BE, London NW1 2PG, Sheffield S10 2RX 

ClinicalTrials.gov ID: NCT04960709

 

A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

This open-label, First-into-Human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK) and early efficacy of AVA6000, a FAP-activated pro-drug of doxorubicin, in patients with locally advanced and/or metastatic solid tumours. In Phase Ia, using a 3+3 design, escalating doses of AVA6000 will be administered to patients with a range of solid tumour types to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). In Phase 1b, the selected RP2D dose will be assessed in one to three tumour types.

The Beatson West of Scotland Cancer Centre Glasgow,  St James's University Hospital Leeds,  The Royal Marsden, NHS Foundation Trust, London,  The Christie NHS Foundation Trust, Manchester,  The Freeman Hospital, Newcastle-upon-Tyne,  Weston Park Cancer Centre Sheffield

ClinicalTrials.gov Identifier: NCT04969835

 

HMBD-001 in Advanced HER3 Positive Solid Tumours

This study evaluates HMBD-001 for treating people with bladder cancer who test positive for the HER3 biomarker. The main aims are to find out the maximum dose of HMBD-001 that can be given safely to patients alone and in combination with other anti-cancer agents, more about the potential side effects of HMBD-001 and how these can be treated.

Royal Marsden NHS Foundation Trust, London,  Churchill Hospital, Oxford

ClinicalTrials.gov Identifier: NCT05057013

 

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Urothelial Bladder Cancer (mUBC)

Guys and St Thomas Hospital, London

ClinicalTrials.gov Identifier NCT05077709

 

A Study of NX-1607 in Adults With Advanced Malignancies

This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies

Royal Marsden Hospital NHS Foundation Trust, Sutton,  University College London Hospitals NHS Foundation,  Addenbrookes Cambridge University Hospital, Cambridge,  Beatson West of Scotland Cancer Centre, Glasgow,  Sarah Cannon Research Institute, London,  The Christie NHS Foundation Trust, Manchester,  Churchill Hospital, Oxford

ClinicalTrials.gov ID: NCT05107674

 

Ex VIvo DEtermiNed Cancer Therapy (EVIDENT)

EVIDENT's aim is to test if ex vivo drug screening can predict whether patients with solid cancers will respond, or not respond, to standard care treatments. Patients undergoing standard care surgery to excise their tumour, those undergoing a biopsy, or those having a fluid aspirate of a solid tumour with surplus tissue available after diagnostic use will be eligible for this study. The specimen will then be assessed with ex vivo drug screening utilising all standard therapies and therapies that are more novel and in early stages of development. The results of the ex vivo drug screen will be compared to the cancer's actual response to standard care treatments for those that undergo therapy to determine how effective the test is at predicting treatment response.

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

ClinicalTrials.gov ID:  NCT05231655

 

Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC).

Through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for MIBC. Our study consists of a discrete choice experiment (DCE): a type of questionnaire used to elicit preferences in the absence of data. DCEs are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. Participants undertaking our DCE questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".

Guy's and St Thomas' NHS Foundation Trust, London

ClinicalTrials.gov ID: NCT05236218

 

Exploiting the Gut Microbiota and Its Metabolites in Pelvic Cancer

The gut bacteria can potentially influence responses to treatments in cancer by helping to change the responses to radiotherapy and chemotherapy. The interactions between these bacteria and the rest of our cells are only now becoming understood and there is little research on the interactions between these bacteria and cancer radiotherapy treatments in pelvic cancer

Aberdeen Royal Infirmary, Aberdeen

ClinicalTrials.gov ID: NCT05605353

 

Find out more about how we can support trials and research.

Please contact us direct for any further information requirements on 01844 351621 or email us direct at info@fightbladdercancer.co.uk 

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We’ve tried to make the information on this site as accurate as possible. Whilst we have support from medical professionals to review the general medical content of this site, please remember that only your medical team can give you specific advice about your symptoms or illness. Fight Bladder Cancer is a registered Charitable Incorporated Organisation in Scotland (SC051881), England and Wales (1198773), and was initially established as an unincorporated charity in England and Wales (1157763). It also operates in Northern Ireland.