RecruitingPhase 1

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

United States20 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed urothelial carcinoma will be eligible for the trial, except for small cell or neuroendocrine component * Participants must have received no prior systemic chemotherapy for this disease. Participants must refuse conventional radio-sensitizing chemotherapy, (and/or) must not be eligible for or refuse cystectomy while on study Participants may receive cystectomy following the end of treatment (EOT)/ Safety Visit if deemed necessary by their clinical team while still in follow-up. * Performance status: ECOG Performance status ≤ 2 * Participants must have normal organ and marrow function as defined below: * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x laboratory upper limit of normal (ULN) * Total serum bilirubin ≤ 2.0 x ULN * Absolute neutrophil count (ANC) ≥ 1500/μL * Platelets ≥ 100,000/μL * Hemoglobin ≥ 9.0 g/dL * Serum calcium ≤ 12.0 mg/dL * Calculated Creatinine Clearance ≥ 30 mL/min. Calculated using Cockcroft-Gault formula: Creatinine Clearance = \[\[140 - age(yr)\] multiplied by body weight(kg)\]/ \[72 multiplied by serum Cr(mg/dL)\] (multiply total by 0.85 for women). * Participants must have adequate baseline bladder function to warrant bladder preservation as asses…

What they're measuring

Rate of acute-dose limiting toxicities

Timeframe: Within 6 months

Trial details

NCT IDNCT05833867

SponsorShilpa Gupta, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Shilpa Gupta, MD

1-866-223 8100 TaussigResearch@ccf.org