RecruitingPhase 1NCT06586255

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

10 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy (a cancer-fighting drug that activates your immune system) to radiation therapy after bladder removal surgery can reduce the risk of bladder cancer coming back in people with high-risk disease. **You may be eligible if...** - You have urothelial carcinoma of the bladder (including certain variant subtypes) - You are considered high risk for recurrence after surgery - You have not previously received immunotherapy (anti-PD1/PD-L1 therapy) - Your overall health and organ function are within acceptable ranges **You may NOT be eligible if...** - You have already received immunotherapy for bladder cancer - You have active autoimmune disease requiring systemic treatment - You have severe immune deficiency or are on high-dose steroids - You have active infections, including HIV or active hepatitis - You are pregnant or breastfeeding 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

RADIATIONConcurrent Immunotherapy and Radiation Therapy

Radiation therapy will begin between 12 to 18 weeks from the start of adjuvant nivolumab. Patients will receive radiation therapy for about 6 weeks.


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06586255


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