A Phase 2 interventional study of Best Practice and Biospecimen Collection in Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma and Refractory Bladder Urothelial Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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Among 11 studies in Urinary Bladder Neoplasms by Mayo Clinic — 6 open to participants now, 7 under way, none of them phase 3. Urinary Bladder Neoplasms · Mayo Clinic.
Among the 11 studies in Urinary Bladder Neoplasms by Mayo Clinic, this one is one of 5 that started in 2025, is one of 3 in phase 2, and was the 10th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →6 of the 11 studies in Urinary Bladder Neoplasms by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 4 1
First in 2016; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 34 across the 6 interventional studies, 204 across the 5 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
2 of the studies in Urinary Bladder Neoplasms by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06891209Mayo ClinicExploration of HRQOL and Urinary Outcomes Following Partial Cystectomy | 2027-01-31 |
| NCT07285044Mayo ClinicThe Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas | 2027-05-15 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies in Urinary Bladder Neoplasms by Mayo Clinic, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The plasma is then removed. The remaining blood components are combined with replacement fluid and returned to the patient's bloodstream through the intravenous or central line. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Treatment with enfortumab vedotin and pembrolizumab is already approved by the Food and Drug Administration for the treatment of bladder cancer, but TPE is not. Combining TPE with enfortumab vedotin and pembrolizumab may work better than standard of care options for treating metastatic and refractory bladder and urinary tract cancers. This study also evaluates the effect of TPE with standard of care antibody drug conjugates (ADCs) in treating patients with refractory metastatic bladder cancer. ADC therapy is treatment with a monoclonal antibody linked to a chemotherapy drug. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, and delivers chemotherapy to kill them. Giving TPE with standard of care ADC therapy may be effective in treating patients with refractory metastatic bladder cancer.
PRIMARY OBJECTIVES:
I. To compare the response rate (overall response rate [ORR]) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 among patients with metastatic bladder cancer (mBCa) who receive therapeutic plasma exchange (TPE) and antibody drug conjugate/immune checkpoint inhibition (ADC/ICI) re-challenge (group A) versus next-line standard of care therapy (group B) after progression on enfortumab vedotin combined with pembrolizumab (EV/pembro). (ReCIPE-B1 [Groups A and B]) II. To evaluate the response rate (ORR) by RECIST version 1.1 among patients with metastatic bladder cancer (mBCa) who receive therapeutic plasma exchange (TPE) and antibody drug conjugate (ADC) re-challenge (Cohort C) versus historical controls after progression on ADC. (CAKE ReCIPE [Cohort C])
SECONDARY OBJECTIVES:
I. To evaluate and compare the overall survival (OS) of patients receiving TPE and ADC/ICI re-challenge versus next-line standard of care. (ReCIPE-B1 [Groups A and B]) II. To evaluate and compare the duration of response (DOR) by RECIST 1.1 between the arms. (ReCIPE-B1 [Groups A and B]) III. To evaluate and compare progression-free survival (PFS) by RECIST 1.1 between the arms. (ReCIPE-B1 [Groups A and B]) IV. To evaluate safety as assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in both treatment arms. (ReCIPE-B1 [Groups A and B]) V. To evaluate patients' quality of life (QoL) among both treatment arms as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) at baseline and every 12 weeks. (ReCIPE-B1 [Groups A and B]) VI. To evaluate the overall survival (OS) of patients receiving TPE and ADC re- challenge. (CAKE ReCIPE [Cohort C]) VII. To evaluate the duration of response (DOR) by RECIST 1.1. (CAKE ReCIPE [Cohort C]) VIII. To evaluate progression-free survival (PFS) by RECIST 1.1. (CAKE ReCIPE [Cohort C]) IX. To evaluate safety as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. (CAKE ReCIPE [Cohort C]) X. To evaluate patients' quality of life (QoL) as assessed by EORTC QLQ-CIPN20 at baseline and every 12 weeks. (CAKE ReCIPE [Cohort C])
CORRELATIVE OBJECTIVE:
I. To use circulating exosomes, circulating tumor deoxyribonucleic acid (DNA), and urine tumor DNA for identifying predictive biomarkers of response, progression, or relapse.
OUTLINE: Patients are randomized to 1 of 2 groups. Patients are assigned to Cohort C.
GROUP A: Patients undergo TPE via venous access or central line on days 1-3 of cycles 1-3 and receive enfortumab vedotin intravenously (IV) over 30 minutes on days 3 and 10 of cycles 1-3 and on days 1 and 8 of cycle 4 and beyond and pembrolizumab IV over 30 minutes on day 3 of cycles 1-3 and day 1 of cycles 4 and beyond. Cycles repeat every 21 days in the absence of disease progression of unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) and collection of blood and urine samples throughout the study. Patients may undergo central line placement prior to TPE.
GROUP B: Patients receive physician's choice of standard of care next-line therapy. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study.
COHORT C: Patients undergo TPE via venous access or central line on days 1-3 of cycles 1-3 only and receive physician's choice of standard of care ADC IV on day 3 of cycles 1-3 and on day 1 of cycles 4 and beyond. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
GROPUS A and B (reCIPE-B1): proven urothelial carcinoma [American Joint Committee on Cancer (AJCC) 2017] of the bladder (BCa) or upper urothelial tract (UTUC), that has progressed despite enfortumab vedotin and pembrolizumab treatment
COHORT C (CAKE ReCIPE): Histologically proven urothelial carcinoma (AJCC 2017) of the bladder (BCa) or upper urothelial tract (UTUC), that has progressed despite ADC AND is otherwise not a candidate for Groups A and B
Exclusion Criteria:
Any of the following because this study involves an agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
Active (i.e., progressing or requiring treatment change ≤ 24 months before registration) other than the disease being treated under study
EXCEPTIONS:
Localized prostate cancer (T1c/T2N0M0):
History of uncontrolled cardiovascular disease including any of the following ≤ 6 months prior to registration:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo TPE via venous access or central line on days 1-3 of cycles 1-3 and receive enfortumab vedotin IV over 30 minutes on days 3 and 10 of cycles 1-3 and on days 1 and 8 of cycle 4 and beyond and pembrolizumab IV over 30 minutes on day 3 of cycles 1-3 and day 1 of cycles 4 and beyond. Cycles repeat every 21 days in the absence of disease progression of unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study. Patients may undergo central line placement prior to TPE.
Procedure: Biospecimen Collection · Procedure: Central Venous Cannula Insertion · Procedure: Computed Tomography · Drug: Enfortumab Vedotin · Procedure: Magnetic Resonance Imaging · Biological: Pembrolizumab · Procedure: Plasmapheresis · Procedure: Positron Emission Tomography · Other: Questionnaire Administration
Patients receive physician's choice of standard of care next-line therapy. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study.
Other: Best Practice · Procedure: Biospecimen Collection · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Questionnaire Administration
Patients undergo TPE via venous access or central line on days 1-3 of cycles 1-3 only and receive physician's choice of standard of care ADC IV on day 3 of cycles 1-3 and on day 1 of cycles 4 and beyond. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI and collection of blood and urine samples throughout the study.
Procedure: Biospecimen Collection · Procedure: Central Venous Cannula Insertion · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Procedure: Plasmapheresis · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Biological: Antibody-Drug Conjugate Therapy
Receive standard of care
Also known as: standard of care, standard therapy
Undergo collection of blood and urine samples
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo central line placement
Also known as: Central venous catheter, Central Venous Catheter Placement
Undergo CT or PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Given IV
Also known as: AGS 22ME, AGS-22M6E, Anti-Nectin 4 ADC ASG-22CE, Anti-nectin-4 Monoclonal Antibody-Drug Conjugate AGS-22M6E, ASG 22CE, ASG-22CE, ASG22CE, Enfortumab Vedotin-ejfv, Padcev
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Given IV
Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475
Undergo TPE
Also known as: Plasma Exchange, Therapeutic Plasma Exchange, Therapeutic Plasmapheresis
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Ancillary studies
Given IV
Overall response rate (ORR) (Groups A and B)
ORR is defined as proportion of evaluable patients with complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: Up to 6 months
ORR (Cohort C)
ORR is defined as proportion of evaluable patients with complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: Up to 6 months
Duration of response (DOR) (Groups A and B)
Duration of response is defined as the time from date of objective response (CR or PR) to date of progression per RECIST 1.1 or death due to all causes, whichever occurs first.
Time frame: Up to 5 years
DOR (Cohort C)
Duration of response is defined as the time from date of objective response (CR or PR) to date of progression per RECIST 1.1 or death due to all causes, whichever occurs first.
Time frame: Up to 5 years
Overall survival (OS) (Groups A and B)
OS is defined as the time from the date of randomization to the date of death due to all causes.
Time frame: Up to 5 years
OS (Cohort C)
OS is defined as the time from the date of randomization to the date of death due to all causes.
Time frame: Up to 5 years
Progression-free survival (PFS) (Groups A and B)
PFS is defined as the time from the date of study randomization (assignment to study arm) to the date of death due to all causes or disease progression per RECIST 1.1.
Time frame: Up to 5 years
PFS (Cohort C)
PFS is defined as the time from the date of study randomization (assignment to study arm) to the date of death due to all causes or disease progression per RECIST 1.1.
Time frame: Up to 5 years
Incidence of adverse events (AEs) (Groups A and B)
AEs will be assessed per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 5 years
Incidence of AEs (Cohort C)
AEs will be assessed per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 5 years
Quality of life - EORTC QLQ-CIPN20 (Groups A and B)
Quality of life will be measured by change in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (QLQ-CIPN20) scores, a 20-item questionnaire used to assess the severity of neuropathy symptoms experienced by cancer patients during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2= a little, 3=quite a bit, and 4=very much. Higher scores indicate greater severity of symptoms.
Time frame: Baseline; every 12 weeks (every 4 cycles) until treatment completion, up to 5 years
Quality of life - EORTC QLQ-CIPN20 (Cohort C)
Quality of life will be measured by change in EORTC QLQ-CIPN20 scores, a 20-item questionnaire used to assess the severity of neuropathy symptoms experienced by cancer patients during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2= a little, 3=quite a bit, and 4=very much. Higher scores indicate greater severity of symptoms.
Time frame: Baseline; every 12 weeks (every 4 cycles) until treatment completion, up to 5 years
Plan to share: No
Started Aug 2025 (actual). Primary completion is estimated for Aug 2028, 36 months after the start.
Of 155 non-industry phase 2 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 103. This study's planned 36 months is below that.
Counting every sponsor, half of 194 studies reached it within 52 months; a quarter within 36 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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