RECRUITING

Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

Conditions

Urothelial Carcinoma Bladder Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer

Quick Facts

Study Start:2024-11

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06586255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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)	* 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

Inclusion Criteria

Exclusion Criteria

* 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)

* 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

Contacts and Locations

Study Contact

Project Manager

CONTACT

215-662-3790

RadOncCRU@PennMedicine.upenn.edu

Principal Investigator

John Christodouleas, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

John Christodouleas, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-11

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Urothelial Carcinoma Bladder
Bladder Cancer