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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer (NCT06586255) is a Phase 1 interventional studying Urothelial Carcinoma Bladder and Bladder Cancer, sponsored by Abramson Cancer Center at Penn Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Urothelial Carcinoma Bladder, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

RADIATION

Concurrent 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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Pennsylvania
Philadelphia, Pennsylvania, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06586255), the sponsor (Abramson Cancer Center at Penn Medicine), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06586255 clinical trial studying?

The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06586255?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06586255?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06586255. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06586255. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.