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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Shilpa Gupta, MD
Study ID
NCT05833867
Phase
PHASE1
Status
Recruiting
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Conditions

  • Localized Muscle Invasive Bladder Urothelial Carcinoma
  • Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab govitecan — DRUG
    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).
  • Adaptive Radiotherapy — RADIATION
    Concurrently, participants will receive an individualized tailored plan for radiation therapy.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SG + Adaptive radiotherapy
    Sacituzumab Govitecan, IV, 8 mg/kg, 21-day cycles for 1 loading cycle prior to radiation and two subsequent cycles with concurrent adaptive radiotherapy

Primary Outcome Measure

Rate of acute-dose limiting toxicities [ Time Frame: Within 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195
Shila Gupta, MD

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By research site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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