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OncoMatch/Clinical Trials/NCT05879653

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

Is NCT05879653 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including MK-3475 and ASG-22CE for bladder cancer.

Phase 2RecruitingKyoto University HospitalNCT05879653Data as of May 2026

Treatment: MK-3475 · ASG-22CEThis 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.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Required: Stage MIBC, N0M0

first confirmed diagnosis of MIBC... Has clinically non-metastatic bladder cancer (N0M0) determined by imaging

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: pelvic/local radiation therapy

Exception: 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.

Has received prior pelvic/local radiation therapy or any antineoplastic treatment for MIBC

Cannot have received: antineoplastic treatment for MIBC

Exception: 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 pelvic/local radiation therapy or any antineoplastic treatment for MIBC

Cannot have received: anti-PD-1 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anti-PD-L1 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anti-PD-L2 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: checkpoint inhibitor

agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)

Cannot have received: antibody-drug conjugate (ASG-22CE, other MMAE-containing ADCs)

Has received prior therapy with an ASG-22CE or other MMAE-containing ADCs

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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