Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)

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.

Trial Details

NCT ID
NCT05879653
Phase
PHASE2
Sponsor
Kyoto University Hospital
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • MK-3475
  • ASG-22CE
  • maximal TURBT
  • Radiation therapy
Locations (sample)
  • Kobe, Hyōgo, Japan|34.6913,135.183
  • Tsukuba, Ibaraki, Japan|36.08333,140.11667
  • Kyoto, Kyoto, Japan|35.02107,135.75385
  • Osaka, Osaka, Japan|34.69379,135.50107

Key Eligibility Criteria

  • 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 w…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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