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Adjuvant Immunotherapy and Radiation for Bladder Cancer

This study is looking at the safety of giving two treatments together for urothelial bladder cancer: nivolumab (an immunotherapy, which helps your body's immune system fight cancer) and radiation therapy. You might be able to join if you are 18 or older and have pure or mixed variant urothelial carcinoma (a type of bladder cancer). The main goal is to see how safe it is to receive both nivolumab and radiation therapy at the same time. This is a small study, planning to enroll 10 people. The study status is currently unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase I study, focusing on safety, and plans to enroll 10 participants.
What's involved
You will receive nivolumab, and radiation therapy will start 12 to 18 weeks after nivolumab begins. Radiation therapy will last for about 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be measured within 18 weeks from the start of radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06586255

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~10 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Concurrent Immunotherapy and Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of concurrent adjuvant immunotherapy and radiation therapy
Measured over Within 18 weeks from start of radiation therapy

Conditions

Urothelial Carcinoma Bladder
Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT06586255

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John Christodouleas, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Project Manager
[email protected]
215-662-3790
Email the study team

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Eligibility criteria

Inclusion

Pure or mixed variant urothelial carcinoma
squamous differentiation
glandular differentiation
nested pattern
microcystic
micropapillary
lymphoepthelioma-like
plasmacytoid and lymphoma-like
sarcomatoid/carcinosarcoma
giant cell
trophoblastic differentiation
clear cell
lipid cell
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 the following minimum diagnostic work-up within 3 months of a patient's consent to participate.
History and physical examination
Chest imaging by x-ray (PA and lateral views), CT scan (with or without IV contrast) or as part of a FDG PET-CT;
Axial abdominal and pelvic imaging by MRI (preferably with gadolinium), CT scan (with or without IV contrast) or as part of a FDG PET-CT;
Patients with microscopically involved (positive) surgical margins, but no grossly evident residual disease by imaging or physical exam are eligible.
The patient is a candidate for definitive external beam radiotherapy;
No prior radiotherapy to the region of study;
No inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist;
Age greater than or equal to 18 years
ECOG performance status: 0-2
Concurrent non-investigational medications will be permitted
In addition to diagnostic staging scan, patient will be considered eligible only if he/she has a CT simulation scan that does not show any evidence of recurrent disease
Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility)

Exclusion

Urinary diversion with an orthotopic neobladder
History of inflammatory bowel disease
Prior partial or complete small bowel obstruction either before or after radical cystectomy
Prior radiotherapy to the pelvis;
Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments
The therapy was completed more than two weeks prior to the start of adjuvant pelvic radiation
The participant has recovered to Grade ≤1 toxicity from agents previously administered, excluding toxicities that would not be expected to impact eligibility for radiation therapy including but not limited to neuropathy, alopecia and hearing loss.
Subtotal surgical resection with clinically evident residual disease by physical exam or axial imaging.
Prior or concurrent second invasive malignancy that, in the judgment of the investigator, may affect interpretation of the results.
Known severe, active co-morbidity, defined as follows:
Patients who experienced Grade 3+ GI toxicity due to surgery or nivolumab prior to enrollment in the trial

What this trial measures

  • Safety of concurrent adjuvant immunotherapy and radiation therapyWithin 18 weeks from start of radiation therapy

    The primary study endpoint is acute grade 3 or higher pelvic radiation related toxicity. A toxicity will be classified as related to pelvic radiation if the toxicity involves or is the result of effects on tissues that are within the 50% isodose bath of the radiation treatment as defined on the radiation treatment planning simulation scan. Toxicities will be graded by CTCAE Version 5.0. Concurrent adjuvant immunotherapy and radiation will be deemed safe if it is likely (i.e. a posterior probability of 50% or greater) that the acute grade 3 or higher pelvic radiation related toxicity rate is \<20%.