Actively Recruiting
Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)
Led by Kyoto University Hospital · Updated on 2025-08-29
30
Participants Needed
4
Research Sites
208 weeks
Total Duration
On this page
Sponsors
K
Kyoto University Hospital
Lead Sponsor
U
University of Tsukuba
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- First confirmed diagnosis of muscle invasive bladder cancer with predominantly urothelial histology obtained within 90 days prior to enrollment
- Clinically non-metastatic bladder cancer (N0M0) confirmed by imaging
- Male participants agree to use contraception and not donate sperm during and after study treatment
- Female participants are not pregnant or breastfeeding and either not of childbearing potential or agree to contraceptive guidance during and after treatment
- Provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function confirmed by laboratory tests within 10 days before first treatment
You will not qualify if you...
- Presence of diffuse carcinoma in situ (CIS) with four or more foci throughout the bladder
- Urothelial carcinoma outside the urinary bladder in the past 2 years except certain low-grade upper tract tumors after nephroureterectomy
- Small cell or neuroendocrine tumor components
- Active malignancy requiring treatment within past 3 years except some skin or superficial cancers
- Limited bladder function with frequent small urine amounts, incontinence, or catheter use
- Prior pelvic radiation therapy or antineoplastic treatment for muscle invasive bladder cancer
- Previous therapy with anti-PD-1/PD-L1/PD-L2 or ASG-22CE or related agents
- Live vaccine within 30 days before first treatment
- Current participation in other investigational studies within 3 months
- Positive pregnancy test for women of childbearing potential
- Uncontrolled diabetes or significant neuropathy
- Active keratitis or corneal ulceration
- Recent radiotherapy or related toxicities requiring corticosteroids
- Immunodeficiency or ongoing immunosuppressive therapy
- Severe allergy to study drugs
- Active autoimmune disease needing systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV, active Hepatitis B or C infections
- Incomplete recovery from major surgery
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnant or lactating individuals or those planning pregnancy
- History of organ transplant
- Recent serious cardiovascular events
- Other conditions or situations that may interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan, 650-0047
Actively Recruiting
2
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan, 305-8576
Actively Recruiting
3
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
Actively Recruiting
4
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan, 545-8586
Actively Recruiting
Research Team
Y
Yuki Kita, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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