Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer

NCT06586255 | Recruiting Phase 1 FDA Device

• 2 other identifiers: UPCC 16824856691
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urothelial Carcinoma Bladder; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Safety of concurrent adjuvant immunotherapy and 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%.

  Within 18 weeks from start of radiation therapy

Study Arms (1)

Concurrent Immunotherapy and Radiation Therapy

EXPERIMENTAL

Subjects will receive the standard of care procedures and follow-up for immunotherapy and radiation therapy. The part of this study that is research is receiving both of these treatments at the same time.

Radiation: Concurrent Immunotherapy and Radiation Therapy

Interventions

Concurrent Immunotherapy and Radiation Therapy RADIATION

Radiation therapy will begin between 12 to 18 weeks from the start of adjuvant nivolumab. Patients will receive radiation therapy for about 6 weeks.

Concurrent Immunotherapy and Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• John Christodouleas, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

215-662-3790; RadOncCRU@PennMedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: April 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)