Actively Recruiting
Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for Urothelial Bladder Cancer
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-05-14
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of giving immunotherapy and radiation therapy at the same time as additional treatment for patients with urothelial bladder cancer. This Phase I study focuses on assessing the side effects, especially acute toxicity, that may happen when these two treatments are combined after surgery. The goal is to understand if this combined approach is safe for patients who have had bladder cancer surgery. Participants will receive standard immunotherapy and radiation therapy treatments together. Radiation therapy will start between 12 and 18 weeks after beginning adjuvant nivolumab and will continue for about 6 weeks. The study treatment involves receiving both therapies concurrently, which is the main research focus. Patients will continue to have standard care and follow-up during the study. During the study, patients will be monitored closely with standard examinations and imaging to assess safety within 18 weeks from the start of radiation therapy. Researchers will track any side effects and acute toxicities related to the combined treatments. Participation involves regular visits for treatments and evaluations, including scans and physical exams, to ensure ongoing safety and response to therapy. The study is expected to continue until April 2027.
CONDITIONS
Brief Title
Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pure or mixed variant urothelial carcinoma, including subtypes such as squamous differentiation, glandular differentiation, nested pattern, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid and lymphoma-like, sarcomatoid/carcinosarcoma, giant cell, trophoblastic differentiation, clear cell, lipid cell, and undifferentiated
- Radical cystectomy and pelvic lymph node dissection within the prior 48 weeks
- Pathologic T3 or higher stage disease, any N, M0 (AJCC, 7th Ed., Appendix C)
- Receiving adjuvant checkpoint inhibitor therapy
- No clinical evidence of residual or recurrent disease based on history, physical exam, chest imaging, and abdominal/pelvic imaging within 3 months prior to consent
- Patients with microscopically involved surgical margins but no gross residual disease are eligible
- Candidate for definitive external beam radiotherapy with no prior radiotherapy to the study region
- No inflammatory bowel disease, active collagen vascular or connective tissue disorders, or other medical/social contraindications to radiotherapy
- Age 18 years or older
- ECOG performance status 0-2
- Concurrent non-investigational medications permitted
- CT simulation scan shows no evidence of recurrent disease
- Ability to understand and sign informed consent
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 radical cystectomy
- Prior radiotherapy to the pelvis region
- Planned concurrent chemotherapy or investigational drug with radiation treatments
- Subtotal surgical resection with clinically evident residual disease
- Prior or concurrent second invasive malignancy affecting study results
- Known severe, active co-morbidity that interferes with treatment or study procedures
- Grade 3 or higher gastrointestinal toxicity due to surgery or nivolumab before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiation therapy for about 6 weeks starting between 12 to 18 weeks from the start of immunotherapy
Participants receive concurrent immunotherapy and radiation therapy as part of their treatment.
Weekly visits for about 6 weeks during radiation therapy
Duration - Up to 18 weeks from start of radiation therapy
Participants are monitored for safety based on acute toxicity after completing concurrent treatment.
Visits scheduled as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
P
Project Manager
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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