Invasive Bladder CancerPhase 1PLUMMBNCT02560636
Pembrolizumab in Muscle Invasive/Metastatic Bladder Cancer
A Phase 1 study testing Pembrolizumab and Radiotherapy in people with Invasive Bladder Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study will also investigate two different doses of pembrolizumab, starting at 100mg (through an intravenous drip) and increasing to 200mg for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Bladder Cancer
- What is being tested?
- Pembrolizumab and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2016to 30 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive bladder.carcinoma (T2-4,N0-3,M0-1).
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1. , or, in group A, disease assessable by cystoscopic assessment.
- Have consented to analysis of tissue from an archival tissue sample
- Have a performance status of 0-1 on the ECOG Performance Scale.
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- Planned for hypofractionated radiotherapy
- Demonstrate adequate organ function as defined in table 2 (please see protocol) all screening blood tests should be performed within 10 days of confirmation of eligibility.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to confirmation of study eligibility. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy if their partner has childbearing potential (as defined by not being surgically sterilized or have not been free from menses for > 1 year).
Who cannot join
- The subject must be excluded from participating in the trial if the subject:
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Previous pelvic radiotherapy, history of inflammatory bowel disease or other conditions that would in the opinion of the investigator would preclude the safe administration of pelvic radiotherapy.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>dose equivalent to 10mg of Prednisolone/day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent or therapy.
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- Note: Subjects with ≤ Grade 2 neuropathy or chemotherapy induced alopecia/nail changes are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer (≤T2 ≤ Gl3+4) or in situ cervical cancer that has undergone potentially curative therapy. Patients may have received treatment for previous urothelial malignancy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known clinical history of Hepatitis B or Hepatitis C .
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Biomedical Research Centre at RM and ICR (https://www.cancerbrc.org/)
Sutton, SM2 5PT
About this study
Official title: Phase I Study of Hypofractionated Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) in the Treatment of Advanced Bladder Cancer
PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study will also investigate two different doses of pembrolizumab, starting at 100mg (through an intravenous drip) and increasing to 200mg for the next cohort of patients, if the first dose is well tolerated. The patients suitable for this study will be: Group A those with locally advanced bladder cancer or Group B patients whose cancer has spread from the bladder (metastatic bladder cancer).
Treatment in the PLUMMB trial will start with a pembrolizumab 2 weeks prior to starting a course of 4 - 6 weeks radiotherapy. Treatment with pembrolizumab will then be given every three weeks. Patients in Group A will then continue to take pembrolizumab for up to a year unless they have disease progression or unacceptable side effects in the meantime. Patients in Group B will continue taking pembrolizumab for as long as needed until they have disease progression or unacceptable side effects.
Patients will be seen every 3 weeks during treatment and every 3-6 months thereafter. CT scans will be done every 3 months during treatment and as per usual care (usually 6 monthly) after the treatment has finished. Patients in Group A will also have a cystoscopy (camera test) to look into the bladder 3 months after they finish radiotherapy. This is standard care and would be the same for patients not on a research study.
Read the detailed description
- Risk and burden for patients Patients in this study have cancer that often proves hard to control with standard care. The early phase nature of this study means that the intervention may not have any benefit for patients who take part in the study. However, they will still receive the standard treatment of radiotherapy. Throughout the study, any patients who have significant side effects from the trial drug will be withdrawn from the trial and will still be eligible to receive standard care. The study itself carries a number of potential burdens:
- Experimental nature of the study drug. The drug stimulates the immune system to produce more proteins that will attack the tumour cells. It is thought that this will be selective for tumour cells; however it is possible that effects on normal tissues may cause side effects. These risks will be managed as much as possible by regular (3 weekly) clinical assessments as a hospital outpatient, by experienced clinicians while having the study treatment. Comprehensive assessments for safety will be carried out including more intensive monitoring with blood tests.
- Burden of frequent hospital visits and tests. Participants in this study must attend hospital frequently for safety reasons to check for any toxicity of the study treatment. Blood tests (more than usual), clinical examination and urine tests are part of the safety assessment.
- Additional investigations may be carried out as part of the study, for research purposes for which consent will be sought form the patient, such as additional blood samples and additional scans (CT thorax, abdomen and pelvis).
- Phase 1 trial of Pembrolizumab: Patients will be carefully monitored for toxicity throughout the trial. A phase I trial has already been conducted to determine the maximum tolerated dose (MTD) of pembrolizumab in bladder cancer. To date no MTD has been defined and the maximum dose tested showed acceptable toxicity and positive effects on reducing tumour size. This study will assess two dose levels of pembrolizumab: 100mg and 200mg and differing radiotherapy doses (24-30Gy in 4-6f). Dose escalation will only occur if the current cohort have shown no signs of unacceptable toxicity at 6 weeks after completing radiotherapy.
- Recruitment Participants will be offered information about this study by their clinical teams if they are considered to meet the entry criteria and express interest in taking part in an experimental study. It will be made clear that the study is experimental in nature and that there will not necessarily be a therapeutic benefit from taking part in the study. It will also be made clear that, should patients decide not to take part their future care will not be affected. Patients will be given sufficient time and information to make an informed decision about entering the trial, and not less than 24 hours; all patients entering the trial will give written informed consent. Inclusion and exclusion criteria for this study are standard for a phase 1 trial of a new oncology drug.
- Confidentiality Patients will be linked to a unique identifier the code for which will be held on a password protected database held only by the study team. Blood samples, tumour sample processing and other data analysis will take place at the laboratories of Royal Marsden and Institute of Cancer Research in London or Sutton. Sample processing will take place using the study number only. No other patient identifiable information will be available on study samples. Investigators will have access to patient identifiable information on password protected NHS hospital notes and databases only.
- Conflict of Interest Patients may be recruited to the study by those involved in their prior clinical care. The investigators do not expect conflict of interest between research and healthcare duties for a number of reasons: patients must give their full informed consent before entering the study, specifically regarding the unknown efficacy of the study drug and the intensive nature of the study. Those patients who do not continue in the study will maintain a relationship with the clinical team if required for symptom control. At the end of the study, patients will be able to access the results if they wish, through the Royal Marsden Website or contact the study team directly.
- Use of tissue samples in future research
If participants give their consent, any leftover blood or tissue samples which are not required for this study will be stored for future unspecified research in line with the human tissue act regulations. Access and use of samples for research purposes will require appropriate ethical approval. Future researchers will not be able to identify individual patients from their biobank data, demographic and clinical information will be available.
- Conditions
- Invasive Bladder Cancer
- Being tested
- Pembrolizumab, Radiotherapy
- Keywords
- Muscle Invasive, Metastatic, Advanced
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475/pembrolizumab (KEYTRUDA®)
Pembrolizumab - Trial Treatment
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1a | Experimental | Radiotherapy: 24Gy in 6f Pembrolizumab: 100mg Receives: Drug: Pembrolizumab; Radiation: Radiotherapy |
| Dose level 1b | Experimental | Radiotherapy: 24Gy in 6f Pembrolizumab: 200mg Receives: Drug: Pembrolizumab; Radiation: Radiotherapy |
| Dose level 2a | Experimental | Radiotherapy: 24Gy in 4f Pembrolizumab: 100mg Receives: Drug: Pembrolizumab; Radiation: Radiotherapy |
| Dose level 2b | Experimental | Radiotherapy: 24Gy in 4f Pembrolizumab: 200mg Receives: Drug: Pembrolizumab; Radiation: Radiotherapy |
| Dose level 3a | Experimental | Radiotherapy: 30Gy in 5f Pembrolizumab: 200mg Receives: Drug: Pembrolizumab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing the maximum tolerated dose (MTD)
Establishing the maximum tolerated dose (MTD) that can be safely combined with hypofractionated radiotherapy to the bladder in the absence of dose limiting toxicity (DLT) by assessing adverse events in the patient population.
Measured: up to 36 months
Measurement of the rates of toxicity
Adverse events will be graded and assessed by CTCAEv4.
Measured: 6 weeks after the last fraction of radiotherapy has been administered
Secondary outcomes (3)
Measurement of the percentage of patients experiencing late grade 2+ and 3+ toxicity
Late grade 2+ and 3+ adverse events will be assessed by CTCAEv4.
Measured: 6 weeks and one day following the completion of radiotherapy until the 28 days after the patients last dose of Pembrolizumab
Measuring rates of tumour response to treatment.
Determining the proportion of patients treated with the combination of Pembrolizumab and radiotherapy with local control of their bladder cancer (based on cystoscopy and/or diffusion weighted MRI) via RECIST.
Measured: 3 months after completion of radiotherapy
Measurement of progression free and overall survival rate
Measurement of progression free and overall survival rate
Measured: Long term survival followup (reported at 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start6 Jun 2016
- Primary completion15 Jan 2025
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Institute of Cancer Research, United Kingdom, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Professor Robert Huddart, Study director, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560636
- Sponsor's protocol ID
- CCR 4255
- Acronym
- PLUMMB
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2015
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tree AC, Jones K, Hafeez S, Sharabiani MTA, Harrington KJ, Lalondrelle S, Ahmed M, Huddart RA. Dose-limiting Urinary Toxicity With Pembrolizumab Combined With Weekly Hypofractionated Radiation Therapy in Bladder Cancer. Int J Radiat Oncol Biol Phys. 2018 Aug 1;101(5):1168-1171. doi: 10.1016/j.ijrobp.2018.04.070. Epub 2018 May 4.
PubMed 30012528
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Hypofractionated Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) in the Treatment of Advanced Bladder Cancer
- ClinicalTrials.gov ID
- NCT02560636
- Acronym / sponsor ID
- PLUMMB / CCR 4255
- Conditions
- Invasive Bladder Cancer
- Keywords
- Muscle Invasive, Metastatic, Advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Institute of Cancer Research, United Kingdom, National Institute for Health Research, United Kingdom
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PLUMMB is an phase I trial to investigate the safety, tolerability and effectiveness of an immunotherapy drug called Pembrolizumab used in combination with radiotherapy. The study will also investigate two different doses of pembrolizumab, starting at 100mg (through an intravenous drip) and increasing to 200mg for the next cohort of patients, if the first dose is well tolerated. The patients suitable for this study will be: Group A those with locally advanced bladder cancer or Group B patients whose cancer has spread from the bladder (metastatic bladder cancer).
Treatment in the PLUMMB trial will start with a pembrolizumab 2 weeks prior to starting a course of 4 - 6 weeks radiotherapy. Treatment with pembrolizumab will then be given every three weeks. Patients in Group A will then continue to take pembrolizumab for up to a year unless they have disease progression or unacceptable side effects in the meantime. Patients in Group B will continue taking pembrolizumab for as long as needed until they have disease progression or unacceptable side effects.
Patients will be seen every 3 weeks during treatment and every 3-6 months thereafter. CT scans will be done every 3 months during treatment and as per usual care (usually 6 monthly) after the treatment has finished. Patients in Group A will also have a cystoscopy (camera test) to look into the bladder 3 months after they finish radiotherapy. This is standard care and would be the same for patients not on a research study.
Detailed description
- Risk and burden for patients Patients in this study have cancer that often proves hard to control with standard care. The early phase nature of this study means that the intervention may not have any benefit for patients who take part in the study. However, they will still receive the standard treatment of radiotherapy. Throughout the study, any patients who have significant side effects from the trial drug will be withdrawn from the trial and will still be eligible to receive standard care. The study itself carries a number of potential burdens:
- Experimental nature of the study drug. The drug stimulates the immune system to produce more proteins that will attack the tumour cells. It is thought that this will be selective for tumour cells; however it is possible that effects on normal tissues may cause side effects. These risks will be managed as much as possible by regular (3 weekly) clinical assessments as a hospital outpatient, by experienced clinicians while having the study treatment. Comprehensive assessments for safety will be carried out including more intensive monitoring with blood tests.
- Burden of frequent hospital visits and tests. Participants in this study must attend hospital frequently for safety reasons to check for any toxicity of the study treatment. Blood tests (more than usual), clinical examination and urine tests are part of the safety assessment.
- Additional investigations may be carried out as part of the study, for research purposes for which consent will be sought form the patient, such as additional blood samples and additional scans (CT thorax, abdomen and pelvis).
- Phase 1 trial of Pembrolizumab: Patients will be carefully monitored for toxicity throughout the trial. A phase I trial has already been conducted to determine the maximum tolerated dose (MTD) of pembrolizumab in bladder cancer. To date no MTD has been defined and the maximum dose tested showed acceptable toxicity and positive effects on reducing tumour size. This study will assess two dose levels of pembrolizumab: 100mg and 200mg and differing radiotherapy doses (24-30Gy in 4-6f). Dose escalation will only occur if the current cohort have shown no signs of unacceptable toxicity at 6 weeks after completing radiotherapy.
- Recruitment Participants will be offered information about this study by their clinical teams if they are considered to meet the entry criteria and express interest in taking part in an experimental study. It will be made clear that the study is experimental in nature and that there will not necessarily be a therapeutic benefit from taking part in the study. It will also be made clear that, should patients decide not to take part their future care will not be affected. Patients will be given sufficient time and information to make an informed decision about entering the trial, and not less than 24 hours; all patients entering the trial will give written informed consent. Inclusion and exclusion criteria for this study are standard for a phase 1 trial of a new oncology drug.
- Confidentiality Patients will be linked to a unique identifier the code for which will be held on a password protected database held only by the study team. Blood samples, tumour sample processing and other data analysis will take place at the laboratories of Royal Marsden and Institute of Cancer Research in London or Sutton. Sample processing will take place using the study number only. No other patient identifiable information will be available on study samples. Investigators will have access to patient identifiable information on password protected NHS hospital notes and databases only.
- Conflict of Interest Patients may be recruited to the study by those involved in their prior clinical care. The investigators do not expect conflict of interest between research and healthcare duties for a number of reasons: patients must give their full informed consent before entering the study, specifically regarding the unknown efficacy of the study drug and the intensive nature of the study. Those patients who do not continue in the study will maintain a relationship with the clinical team if required for symptom control. At the end of the study, patients will be able to access the results if they wish, through the Royal Marsden Website or contact the study team directly.
- Use of tissue samples in future research
If participants give their consent, any leftover blood or tissue samples which are not required for this study will be stored for future unspecified research in line with the human tissue act regulations. Access and use of samples for research purposes will require appropriate ethical approval. Future researchers will not be able to identify individual patients from their biobank data, demographic and clinical information will be available.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose level 1a | Experimental | Drug: Pembrolizumab, Radiation: RadiotherapyRadiotherapy: 24Gy in 6f Pembrolizumab: 100mg |
| Dose level 1b | Experimental | Drug: Pembrolizumab, Radiation: RadiotherapyRadiotherapy: 24Gy in 6f Pembrolizumab: 200mg |
| Dose level 2a | Experimental | Drug: Pembrolizumab, Radiation: RadiotherapyRadiotherapy: 24Gy in 4f Pembrolizumab: 100mg |
| Dose level 2b | Experimental | Drug: Pembrolizumab, Radiation: RadiotherapyRadiotherapy: 24Gy in 4f Pembrolizumab: 200mg |
| Dose level 3a | Experimental | Drug: Pembrolizumab, Radiation: RadiotherapyRadiotherapy: 30Gy in 5f Pembrolizumab: 200mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed invasive bladder.carcinoma (T2-4,N0-3,M0-1).
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1. , or, in group A, disease assessable by cystoscopic assessment.
- Have consented to analysis of tissue from an archival tissue sample
Key exclusion criteria (20 listed)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Previous pelvic radiotherapy, history of inflammatory bowel disease or other conditions that would in the opinion of the investigator would preclude the safe administration of pelvic radiotherapy.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>dose equivalent to 10mg of Prednisolone/day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent or therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: MK-3475/pembrolizumab (KEYTRUDA®)Pembrolizumab - Trial Treatment | Drug | Dose level 1a, Dose level 1b, Dose level 2a, Dose level 2b, Dose level 3a |
| RadiotherapyRadiotherapy | Radiation | Dose level 1a, Dose level 1b, Dose level 2a, Dose level 2b, Dose level 3a |
Primary outcome
Establishing the maximum tolerated dose (MTD)
Time frame: up to 36 months
Establishing the maximum tolerated dose (MTD) that can be safely combined with hypofractionated radiotherapy to the bladder in the absence of dose limiting toxicity (DLT) by assessing adverse events in the patient population.
Measurement of the rates of toxicity
Time frame: 6 weeks after the last fraction of radiotherapy has been administered
Adverse events will be graded and assessed by CTCAEv4.
3 secondary outcomes
Measurement of the percentage of patients experiencing late grade 2+ and 3+ toxicity
Time frame: 6 weeks and one day following the completion of radiotherapy until the 28 days after the patients last dose of Pembrolizumab
Measuring rates of tumour response to treatment.
Time frame: 3 months after completion of radiotherapy
Measurement of progression free and overall survival rate
Time frame: Long term survival followup (reported at 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 30012528Tree AC, Jones K, Hafeez S, Sharabiani MTA, Harrington KJ, Lalondrelle S, Ahmed M, Huddart RA. Dose-limiting Urinary Toxicity With Pembrolizumab Combined With Weekly Hypofractionated Radiation Therapy in Bladder Cancer. Int J Radiat Oncol Biol Phys. 2018 Aug 1;101(5):1168-1171. doi: 10.1016/j.ijrobp.2018.04.070. Epub 2018 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Robert Huddart study director
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab and Radiotherapy in people with Invasive Bladder Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing the maximum tolerated dose (MTD) (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02560636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.