RecruitingPhase 1NCT05833867

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Bladder Preservation in Patients With MIBC (RAD-SG).

Sponsor

Shilpa Gupta, MD

Enrollment

20 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Muscle-Invasive Bladder Carcinoma Localized Muscle Invasive Bladder Urothelial Carcinoma

Summary

The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy. The main objective is to establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for participants with localized MIBC. Participants will receive the study drug, SG, through an IV once weekly on days 1 and 8 of each 21-day treatment cycle. The first cycle of SG will begin 21 days prior to the scheduled start of radiation therapy. The second and third cycles of SG will be given while the participant is receiving radiation therapy. Participants will be asked to undergo computed tomography (CT) and magnetic resonance imaging (MRI) pre-and post-treatment. Participation in the research will last up to 5 years, depending on treatment outcomes, with a treatment period of 8 weeks and a study follow-up period of up to 2-5 years thereafter, and a survival follow-up, with only phone call communication from years 3-5.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for muscle-invasive bladder cancer (cancer that has grown into the muscular wall of the bladder) that combines a targeted antibody-drug called sacituzumab govitecan with adaptive radiation therapy. The goal is to destroy the cancer while preserving the bladder — an alternative to surgical removal of the bladder for patients who cannot or do not want surgery. **You may be eligible if...** - You have muscle-invasive bladder cancer confirmed by biopsy - You have not received prior chemotherapy for this cancer - You are refusing or ineligible for conventional chemotherapy or surgery - You have undergone a procedure to remove visible tumor tissue (TURBT) within 60 days - Your kidney and blood count levels meet required thresholds - Your general health is good (ECOG score 0–2) **You may NOT be eligible if...** - You have already received systemic chemotherapy for this cancer - Your cancer has spread to other organs (metastatic disease) - You have bilateral kidney obstruction caused by the tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan

8 mg/kg Sacituzumab Govitecan is to be administered intravenously in 21-day cycles on Day 1 and Day 8; the next cycle should start a minimum of 14 days after the Day 8 dose (i.e., the Day 8 infusion will be counted as the first day of that 14-day period).

RADIATIONAdaptive Radiotherapy

Concurrently, participants will receive an individualized tailored plan for radiation therapy.

Locations(1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05833867

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