Trials
Search / Trial NCT06417190

Bladder Preservation for Patients with Muscle Invasive Bladder Cancer (MIBC) with Variant Histology

Launched by LESLIE BALLAS · May 13, 2024

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Trial Information

Current as of March 14, 2025

Recruiting

Keywords

Trimodal Therapy (Tmt) Neoadjuvant Chemotherapy Muscle Invasive Urothelial Cell Bladder Cancer (Mibc)

ClinConnect Summary

This clinical trial is looking at a treatment approach for patients with muscle-invasive bladder cancer (MIBC) that has a variant histology, which means the cancer cells look different from typical bladder cancer cells. The study is designed to evaluate how well patients respond to a combination of chemotherapy and immunotherapy before they undergo a special treatment called trimodal therapy (TMT) that includes chemotherapy, radiation, and surgery. The researchers want to find out if these patients can receive TMT safely within 45 days after their initial chemotherapy and immunotherapy, which could help prevent the cancer from spreading.

To participate in this trial, patients need to have a confirmed diagnosis of MIBC with variant histology and should be able to provide written consent to join the study. Patients with certain conditions, such as having widespread cancer in the bladder or previous pelvic radiation therapy, may not be eligible. Those who join the trial can expect to receive at least three cycles of chemotherapy, possibly combined with immunotherapy, followed by a course of chemotherapy and radiation therapy. This study is currently recruiting participants of all genders, typically between the ages of 65 and 74.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
  • • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  • Exclusion Criteria:
  • • Evidence of diffuse cis on pathology
  • • Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
  • • Prior radiotherapy to the pelvis
  • • History of systemic therapy for MIBS
  • • Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)

Trial Officials

Leslie Ballas, MD

Principal Investigator

Cedars-Sinai Medical Center

About Leslie Ballas

Leslie Ballas is a dedicated clinical trial sponsor committed to advancing medical research and enhancing patient care through innovative studies. With a focus on rigorously designed clinical trials, Leslie Ballas aims to evaluate the safety and efficacy of novel therapeutic interventions across various therapeutic areas. The organization prioritizes collaboration with leading researchers and healthcare professionals to ensure the highest standards of scientific integrity and ethical conduct. By fostering a patient-centric approach, Leslie Ballas strives to contribute to the development of groundbreaking treatments that improve health outcomes and quality of life for patients worldwide.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0