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

NCT05879653 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MK-3475

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.

DRUG

ASG-22CE

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.

PROCEDURE

maximal TURBT

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

Radiation therapy

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).

Sponsors & Collaborators

  • University of Tsukuba

    collaborator OTHER

  • Osaka Metropolitan University

    collaborator OTHER

  • Kobe City Medical Center General Hospital

    collaborator UNKNOWN

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Kyoto University Hospital

    lead OTHER

Principal Investigators

  • Takashi Kobayashi, MD,PhD · Kyoto University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05879653 on ClinicalTrials.gov