New combo therapy for bladder cancer passes first safety test?
NCT ID NCT06586255
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing whether it is safe to give immunotherapy (nivolumab) together with radiation therapy after bladder cancer surgery. The study will enroll 10 people who have had their bladder removed. The main goal is to see if this combination causes serious side effects in the pelvic area. If it proves safe, it could lead to larger studies to see if it helps prevent cancer from returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (immunotherapy) plus radiation therapy
- What this could lead to
- If safe, this combination could become a new treatment option to help prevent bladder cancer from coming back after surgery.
- What could go wrong
- This is a very early Phase I trial with only 10 people, so it is mainly checking safety, not effectiveness. There is a risk of side effects from the radiation and immunotherapy combination.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pure or mixed variant urothelial carcinoma o Allowable mixed variant subtypes include: * 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 Criteria: * 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; o Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participant's prior and current course of radiation therapy, radiotherapy was completed more than four weeks from enrolling in this study. * Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments o Prior chemotherapy or investigational drug for bladder cancer or a different cancer is allowed, provided that: * 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: o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results. * Patients who experienced Grade 3+ GI toxicity due to surgery or nivolumab prior to enrollment in the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?
- Can a radioactive antibody light up hidden tumors on PET scans?
- Can a radioactive drug seek out and attack solid tumors?