BridgeMD
New treatment option for Localized Muscle Invasive Bladder Urothelial Carcinoma
Official title Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT05833867
What this study is testing
What is Sacituzumab govitecan?
Sacituzumab govitecan is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for localized muscle invasive bladder urothelial carcinoma.
Also referred to as TRODELVY.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 8 weeks
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
- Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed...
- Participants must have received no prior systemic chemotherapy for this disease. Participants must refuse conventional radio-sensitizing...
- 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...
You likely can't join if
- Participants receiving or utilizing any other investigational agents or devices.
- Has received prior pelvic / local radiation therapy for MIBC or any other cancer type.
- Has received any prior systemic treatment, chemoradiation, and / or radiation therapy for MIBC or non-muscle-invasive bladder cancer (NMIBC). Note...
- Has diagnosed Bilateral hydronephrosis.
- Has limited bladder function as noted by a provider, with frequency of small amounts of urine, urinary incontinence including stress/urge, requires...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SG or any of its' components.
See the full eligibility 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...
- 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...
- 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...
- Participants must have adequate baseline bladder function to warrant bladder preservation as assessed by the treating provider, including absence of bilateral hydronephrosis or acute obstruction related to bladder tumor...
- Participants must undergo a TURBT within ≤ 60 days prior to treatment start. In a situation where a participant is referred from an outside site to the Cleveland Clinic Foundation, participant must have a repeat...
- Participants may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection.
- Participant must undergo radiological staging within 60 days prior to treatment start. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Participants must not have evidence of T4b and/or N1-3...
- Participants must not have had urothelial carcinoma or any histological variant at any site outside of the urinary bladder within the previous 24 months except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract...
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
- Participants receiving or utilizing any other investigational agents or devices.
- Has received prior pelvic / local radiation therapy for MIBC or any other cancer type.
- Has received any prior systemic treatment, chemoradiation, and / or radiation therapy for MIBC or non-muscle-invasive bladder cancer (NMIBC). Note: Prior treatment for NMIBC with intravesical instillation therapy such...
- Has diagnosed Bilateral hydronephrosis.
- Has limited bladder function as noted by a provider, with frequency of small amounts of urine, urinary incontinence including stress/urge, requires self-catheterization or a permanent indwelling catheter.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SG or any of its' components.
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or...
- Pregnant or breastfeeding women are excluded from this study because SG and radiation effects during pregnancy have potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for...
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Note: Participants who have...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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 study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Cleveland, Ohio, 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.