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OncoMatch/Clinical Trials/NCT05879653

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

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

Phase 2RecruitingKyoto University HospitalNCT05879653Data as of Jun 2026Location: Japan

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

Treatments studied

Other

MK-3475ASG-22CE

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.

Frequently asked questions

Is NCT05879653 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage MIBC or N0M0 is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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