RecruitingPhase 2NCT05072600

Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer

A Pilot Study of Pembrolizumab Monotherapy as Maintenance Therapy in MIBC Patients Who Received Bladder-Preserving Trimodally Therapy and Achieved CR

Sponsor

Peking University First Hospital

Enrollment

54 participants

Start Date

Dec 7, 2021

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Urinary Bladder Cancer Bladder Neoplasms Bladder Tumors Neoplasms, Bladder

Summary

This is a Phase II, single-arm, study of pembrolizumab as maintenance therapy in muscle-invasive bladder cancer (MIBC) participants who have received maximum TURBT and tri-modality treatment (TMT) and achieved CR. All participants will receive pembrolizumab monotherapy per 21 days no longer than 17 cycles until disease progression or death.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing pembrolizumab (an immunotherapy drug) as a maintenance treatment after bladder-preserving therapy for people with muscle-invasive bladder cancer who had a complete response to combined treatment. **You may be eligible if...** - You are 18 or older - You have muscle-invasive bladder cancer (stage cT2–T4, no spread) - You received maximum surgery (TURBT) followed by combined chemotherapy and radiation therapy - You achieved a complete response (no detectable cancer) after that combined treatment - Your tumor was on one side of the bladder wall - Your general health allows participation (ECOG 0–2) **You may NOT be eligible if...** - You previously received immunotherapy (PD-1, PD-L1, CTLA-4 drugs) - Your cancer has spread to other organs or lymph nodes - You are pregnant - You have severe autoimmune disease or active infections 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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