Bladder CancerPhase 2NCT05879653
Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)
A Phase 2 study testing MK-3475, ASG-22CE and maximal TURBT in people with Bladder Cancer, run by Kyoto University Hospital at 4 sites in Japan.
Trial summary
This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- MK-3475, ASG-22CE and maximal TURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesJapan
- Study dates
- 1 Oct 2023to 30 Sep 2027
- Phase
- Phase 2
- 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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male/female participants who are at least 18 years of age on the day of signing informed consent and who have a first confirmed diagnosis of MIBC with predominant urothelial histology obtained via a diagnostic or maximal TURBT within 90 days prior to enrollment.
- Note: Participants with mixed histology are eligible provided the urothelial component is ≥50%.
- Has clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT of the chest and CTU/MRU of abdomen and pelvis), assessed by the site.
- Male participants:
- A male participant must agree to use a contraception and not to donate sperm during the administration of MK-3475 and ASG-22CE and for at least 90 days after the last dose of MK-3475 and for 6 months after ASG-22CE.
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- Female participants:
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of MK3475 and for 6 months after ASG-22CE and RT.
- The participant provides written informed consent for the trial.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- Demonstrates adequate organ function. All screening laboratory tests should be performed within 10 days prior to the first dose of study intervention.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions
- Has the presence of diffuse CIS (multiple foci [4 or greater] of CIS) throughout the bladder.
- Has the presence of UC at any site outside of the urinary bladder in the previous 2 years except for Ta/T1/CIS of the upper tract if the patient has undergone a complete nephroureterectomy.
- Has the presence of any small cell or neuroendocrine component in the tumor tissue sample.
- Has a known additional malignancy that is progressing or has required active therapy within the past 3 years.
Show all 38Show fewer
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or other carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Participants with low-risk prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent any time before screening or untreated in active surveillance are not excluded.
- Has limited bladder function with frequency of small amounts of urine (< 30 mL), urinary incontinence, or requires self-catheterization or a permanent indwelling catheter.
- Has a history of radiation therapy to the pelvic region for any reason.
- Prior/Concomitant Therapy
- Has received prior pelvic/local radiation therapy or any antineoplastic treatment for MIBC.
- Note: Prior treatment for NMIBC with intravesical instillation therapy such as BCG or intravesical chemotherapy is permitted, but must be completed ≥28 days before the first dose of the trial drug. Prior systemic treatment received for treatment of NMIBC is not permitted.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Has received prior therapy with an ASG-22CE or other MMAE-containing ADCs.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Note: please refer to Section 5.5 for information on COVID-19 vaccines Prior/Concurrent Clinical Study Experience
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 months before the first dose of study intervention.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Diagnostic Assessments
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to the first dose of study intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has uncontrolled diabetes. Uncontrol diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- Has ongoing sensory or motor neuropathy Grade 2 or higher.
- Has active keratitis or corneal ulceration. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.
- Has severe hypersensitivity (≥Grade 3) to MK-3475, ASG-22CE and/or any of their excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid).
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection. The test should be performed within 28 days prior to the first dose of the trial drug.
- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. The test should be performed within 28 days prior to the first dose of the trial drug.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant 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.
- Pregnant or lactating, or female patients or male patients who wish to become pregnant from the time of screening to 120 days after the last dose of MK-3475 and 6 months after radiotherapy and the last dose of ASG-22CE, or their partners.
- Has had an allogenic tissue/solid organ transplant.
- Has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to the first dose of the trial drug.
- Or, if participation in this clinical trial is considered inappropriate according to the judgment of the investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan4 sites, 4 recruiting
- Recruiting
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
- Recruiting
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
About this study
Official title: A Phase 2, Open-label, Multi-institutional Study to Evaluate the Efficacy of Induction Therapy With MK-3475 and ASG-22CE Followed by Radiation Therapy With MK-3475 in Patients With MIBC Who Are Unfit for or Refuse Radical Cystectomy
This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy.
- Conditions
- Bladder Cancer
- Being tested
- MK-3475, ASG-22CE, maximal TURBT, Radiation therapy
- Keywords
- Bladder preservation, Radiation therapy, Immunotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-3475Drug
Also called Pembrolizumab
During the induction phase, MK-3475 200 mg will be administered as four cycles of 3-weeks regimen, with ASG-22CE 1.25 mg/kg administered on Day 1 and Day 8 of each cycle. The treatment and maintenance phases will consist of 9 cycles of one course per 6 weeks, with MK-3475 400 mg administered on Day 1 of each course at Q6W.
ASG-22CEDrug
Also called Enfortumab vedotin
During the induction phase, four cycles of 3-weeks regimen are administered, with ASG-22CE 1.25 mg/kg administered on Day 1 and Day 8 of each cycle.
maximal TURBTProcedure or surgery
All participants who were not determined to have PD on imaging during the induction phase should have had a maximal TURBT performed at 13 (± 1week) weeks after the first dose of trial drug.
Radiation therapyRadiation
Radiotherapy will be initiated no later than 8 weeks after maximal TUR-BT. In this trial, a total dose of 56 Gy will be delivered using 2 Gy per dose. 40 Gy/20 fr (2 Gy/fr) to the small pelvis followed by 16 Gy /8 fr (2 Gy/fr) to the whole bladder 5 times a week for 5 consecutive days using Three-Dimensional Conformal Radiation Therapy (3D-CRT).
| Study group | Role | What they receive |
|---|---|---|
| MK-3475 and ASG-22CE With Radiation Therapy | Experimental | Not described Receives: Drug: MK-3475; Drug: ASG-22CE; Procedure: maximal TURBT; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Intact Event-Free Survival (BI-EFS) rate
To evaluate bladder intact event-free survival (BI-EFS) rate at 2 year after study enrollment assessed by cystoscopy, cytology, biopsy results by central pathology review, and imaging evaluation.
Measured: 2 years
Secondary outcomes (13)
Pathologic Complete Response (pCR) Rate at 38 weeks
The pathologic complete response rate is based on the central pathology review of tumor bed biopsies performed at 38 weeks and the results of imaging studies performed by each institution.
Measured: 38 weeks
Overall Survival (OS)
OS is defined as the time from study enrollment to death from any cause.
Measured: 2 years
Metastasis-Free Survival (MFS)
Metastasis-free survival is defined as the time from study enrollment to the first documented evidence of nodal or distant metastases as assessed by CT of chest and CTU or MRU of the abdomen and pelvis and/or biopsy results assessed by central pathology review, or death from any cause. If biopsy is not feasible due to participant safety, the imaging alone will be sufficient.
Measured: 2 years
Number of participants who experienced an adverse event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Measured: 2 years
Number of participants who discontinued study intervention due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Measured: 2 years
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Measured: Baseline and up to approximately 2years
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Measured: Baseline and up to approximately 2years
Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)
The BCI is a validated, condition-specific health questionnaire assessing quality of life among participants with bladder cancer. The BCI contains 36 items which assess 3 domains (urinary, bowel, and sexual) with function and bother subdomains. Scores range from 0 to 100 with higher scores corresponding to better functioning and health-related quality of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.
Measured: Baseline and up to approximately 2years
Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Measured: Baseline and up to approximately 2years
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.
Measured: 2 years
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a better quality of life. TTD in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score is defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.
Measured: 2 years
TTD in Urinary, Bowel, and Sexual Domains of the BCI
The BCI is a validated, condition-specific health questionnaire assessing quality of life among participants with bladder cancer. The BCI contains 36 items which assess 3 domains (urinary, bowel, and sexual) with function and bother subdomains. Scores range from 0 to 100 with higher scores corresponding to better functioning and health-related quality of life. TTD in BCI is defined as a 6, 7, and 7 points or greater worsening from baseline for urinary, bowel, and sexual domains, respectively, with or without subsequent confirmation, under a right-censoring rule.
Measured: 2 years
TTD in the VAS of the EQ-5D-5L
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tsukuba, Osaka Metropolitan University, Kobe City Medical Center General Hospital, Merck Sharp & Dohme LLC, Astellas Pharma Inc
- Responsible party
- Principal investigator, Takashi Kobayashi, Kyoto University Hospital
- Investigators
- Takashi Kobayashi, MD,PhD, Principal investigator, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879653
- Sponsor's protocol ID
- IACT21079
- Status last verified
- Mar 2025
- First submitted
- 10 May 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multi-institutional Study to Evaluate the Efficacy of Induction Therapy With MK-3475 and ASG-22CE Followed by Radiation Therapy With MK-3475 in Patients With MIBC Who Are Unfit for or Refuse Radical Cystectomy
- ClinicalTrials.gov ID
- NCT05879653
- Acronym / sponsor ID
- IACT21079
- Conditions
- Bladder Cancer
- Keywords
- Bladder preservation, Radiation therapy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kyoto University HospitalUniversity, hospital or other
- Collaborators
- University of Tsukuba, Osaka Metropolitan University, Kobe City Medical Center General Hospital, Merck Sharp & Dohme LLC, Astellas Pharma Inc
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 May 2023 (actual)
- 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.
This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-3475 and ASG-22CE With Radiation Therapy | Experimental | Drug: MK-3475, Drug: ASG-22CE, Procedure: maximal TURBT, Radiation: Radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Note: Participants with mixed histology are eligible provided the urothelial component is ≥50%.
- A male participant must agree to use a contraception and not to donate sperm during the administration of MK-3475 and ASG-22CE and for at least 90 days after the last dose of MK-3475 and for 6 months after ASG-22CE.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Key exclusion criteria (38 listed)
- Medical Conditions
- Has the presence of diffuse CIS (multiple foci [4 or greater] of CIS) throughout the bladder.
- Has the presence of UC at any site outside of the urinary bladder in the previous 2 years except for Ta/T1/CIS of the upper tract if the patient has undergone a complete nephroureterectomy.
- Has the presence of any small cell or neuroendocrine component in the tumor tissue sample.
- Has a known additional malignancy that is progressing or has required active therapy within the past 3 years.
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 |
|---|---|---|
| MK-3475Also: PembrolizumabDuring the induction phase, MK-3475 200 mg will be administered as four cycles of 3-weeks regimen, with ASG-22CE 1.25 mg/kg administered on Day 1 and Day 8 of each cycle. The treatment and maintenance phases will consist of 9 cycles of one course per 6 weeks, with MK-3475 400 mg administered on Day 1 of each course at Q6W. | Drug | MK-3475 and ASG-22CE With Radiation Therapy |
| ASG-22CEAlso: Enfortumab vedotinDuring the induction phase, four cycles of 3-weeks regimen are administered, with ASG-22CE 1.25 mg/kg administered on Day 1 and Day 8 of each cycle. | Drug | MK-3475 and ASG-22CE With Radiation Therapy |
| maximal TURBTAll participants who were not determined to have PD on imaging during the induction phase should have had a maximal TURBT performed at 13 (± 1week) weeks after the first dose of trial drug. | Procedure or surgery | MK-3475 and ASG-22CE With Radiation Therapy |
| Radiation therapyRadiotherapy will be initiated no later than 8 weeks after maximal TUR-BT. In this trial, a total dose of 56 Gy will be delivered using 2 Gy per dose. 40 Gy/20 fr (2 Gy/fr) to the small pelvis followed by 16 Gy /8 fr (2 Gy/fr) to the whole bladder 5 times a week for 5 consecutive days using Three-Dimensional Conformal Radiation Therapy (3D-CRT). | Radiation | MK-3475 and ASG-22CE With Radiation Therapy |
Primary outcome
Bladder Intact Event-Free Survival (BI-EFS) rate
Time frame: 2 years
To evaluate bladder intact event-free survival (BI-EFS) rate at 2 year after study enrollment assessed by cystoscopy, cytology, biopsy results by central pathology review, and imaging evaluation.
13 secondary outcomes
Pathologic Complete Response (pCR) Rate at 38 weeks
Time frame: 38 weeks
Overall Survival (OS)
Time frame: 2 years
Metastasis-Free Survival (MFS)
Time frame: 2 years
Number of participants who experienced an adverse event (AE)
Time frame: 2 years
Number of participants who discontinued study intervention due to an AE
Time frame: 2 years
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Baseline and up to approximately 2years
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time frame: Baseline and up to approximately 2years
Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)
Time frame: Baseline and up to approximately 2years
Change from Baseline in the Visual Analog Score (VAS) of the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
Time frame: Baseline and up to approximately 2years
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Time frame: 2 years
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time frame: 2 years
TTD in Urinary, Bowel, and Sexual Domains of the BCI
Time frame: 2 years
TTD in the VAS of the EQ-5D-5L
Time frame: 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 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Takashi Kobayashi, MD,PhD principal investigator
Kyoto University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-3475, ASG-22CE and maximal TURBT in people with Bladder Cancer, run by Kyoto University Hospital at 4 sites in Japan.
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 13 inclusion and 38 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Yuki Kita, MD,PhD (81757513337, kitayuki@kuhp.kyoto-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Intact Event-Free Survival (BI-EFS) rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.