RecruitingPhase 2NCT05879653

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

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

Sponsor

Kyoto University Hospital

Enrollment

30 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two cancer drugs — pembrolizumab (an immunotherapy) and enfortumab vedotin (EV, an antibody-drug conjugate) — along with radiation therapy, in patients with muscle-invasive bladder cancer (MIBC) who want to try to keep their bladder rather than have surgery to remove it. **You may be eligible if...** - You are 18 or older with a confirmed first diagnosis of muscle-invasive bladder cancer (predominantly urothelial type) - Your cancer has not spread to lymph nodes or distant organs - You are in good overall health (ECOG 0–1) - Your organs are functioning adequately **You may NOT be eligible if...** - You have had prior radiation to the pelvis - You have received prior immunotherapy (PD-1/PD-L1) or enfortumab vedotin - You have active autoimmune disease, lung inflammation (pneumonitis), or HIV - You have poorly controlled diabetes (HbA1c 8% or above) - You have active nerve damage (grade 2 or higher neuropathy) - You are pregnant or planning pregnancy - You had a stroke or heart attack within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-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.

DRUGASG-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.

PROCEDUREmaximal 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.

RADIATIONRadiation 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).