Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06586255

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-05-14

10

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of pure or mixed variant urothelial carcinoma, including specific subtypes like squamous or glandular differentiation
  • Radical cystectomy and pelvic lymph node dissection performed within the last 48 weeks
  • Pathologic stage T3 or higher disease with no distant metastasis
  • Currently receiving adjuvant checkpoint inhibitor therapy
  • No clinical evidence of residual or recurrent cancer based on recent history, physical exam, and chest, abdominal, and pelvic imaging
  • Eligible for external beam radiation therapy with no prior radiation to the study region
  • No inflammatory bowel disease, active connective tissue disorders, or medical/social reasons preventing radiation
  • Age 18 years or older
  • ECOG performance status between 0 and 2
  • Concurrent non-investigational medications allowed
  • CT simulation scan shows no recurrent disease
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Urinary diversion with an orthotopic neobladder
  • History of inflammatory bowel disease
  • Prior partial or complete small bowel obstruction before or after bladder surgery
  • Previous radiation therapy to the pelvis overlapping with planned treatment fields
  • Planned chemotherapy or investigational drugs during radiation therapy
  • Subtotal surgical removal with visible residual disease
  • Prior or concurrent second invasive cancer affecting study results
  • Severe active medical conditions that interfere with safe study completion
  • History of Grade 3 or higher gastrointestinal toxicity from surgery or nivolumab before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

P

Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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