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New treatment option for Urothelial Carcinoma Bladder
Official title Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer
ClinicalTrials.gov ID: NCT06586255
What this study is testing
- What it's testing
- The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pure or mixed variant urothelial carcinoma o Allowable mixed variant subtypes include:
- squamous differentiation
- glandular differentiation
- nested pattern
- microcystic
You likely can't join 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...
- Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments o Prior chemotherapy or investigational drug for...
- The therapy was completed more than two weeks prior to the start of adjuvant pelvic radiation
See the full eligibility 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...
- 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...
- 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...
- 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...
- Patients who experienced Grade 3+ GI toxicity due to surgery or nivolumab prior to enrollment in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.