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Monoclonal Antibodies
Pre-Surgery Sacituzumab Govitecan for Bladder Cancer
Phase 2
Recruiting
Led By Petros Grivas
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be at least 18 years of age on the day of signing informed consent
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial tests a drug to treat bladder cancer before surgery to make it more effective.
Who is the study for?
This trial is for adults with muscle invasive bladder cancer who haven't had major surgery or other cancer treatments recently. They must be fit enough for radical cystectomy, not pregnant or breastfeeding, and willing to use contraception. People with neuroendocrine/small cell histology, another interfering malignancy, significant heart disease, active infections requiring antibiotics, or known allergies to the study drug are excluded.Check my eligibility
What is being tested?
The trial is testing Sacituzumab Govitecan given before surgery (radical cystectomy) in patients with non-urothelial bladder cancer. It's a phase II study to see if this targeted therapy that delivers chemotherapy directly to cancer cells can improve surgical outcomes.See study design
What are the potential side effects?
Sacituzumab Govitecan may cause side effects like allergic reactions due to its antibody component and typical chemotherapy-related issues such as nausea, fatigue, hair loss, lowered blood counts increasing infection risk and potential damage to organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I am considered a candidate for bladder removal and lymph node surgery by both my urologist and oncologist.
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My cancer has spread to a lymph node in my pelvis but it can be removed with surgery.
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My bladder cancer diagnosis was confirmed through a biopsy or by doctors agreeing.
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I agree to have surgery aimed at curing my condition.
Select...
My blood clotting time is normal or I am on blood thinners.
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My kidney function, measured by creatinine levels, is within the normal range.
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My bladder cancer has not spread, confirmed by CT or MRI scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response (pCR) rate
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Recurrence free survival (RFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sacituzumab govitecan)Experimental Treatment3 Interventions
Patients receive sacituzumab govitecan IV over 3 hours on days 1 and 8 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after last dose, patients undergo radical cystectomy and pelvic lymph node dissection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphadenectomy
2021
Completed Phase 2
~1480
Radical Cystectomy
2006
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,920 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,083 Previous Clinical Trials
843,341 Total Patients Enrolled
Petros GrivasPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have another cancer that could affect the study's results.I have an active hepatitis B or C infection.Your body has enough infection-fighting cells.I am currently on antibiotics for an infection.I am not suitable for cisplatin treatment or I have refused it after being advised.Your bilirubin levels must be within a certain range.I do not have any serious heart conditions.I am 18 years old or older.I haven't had major surgery or serious injury in the last 3 weeks.You have enough platelets in your blood (at least 100,000 per microliter).I can take care of myself and am up and about more than half of my waking hours.I am considered a candidate for bladder removal and lymph node surgery by both my urologist and oncologist.My bladder cancer surgery was within the last 3 months.I agree to use birth control and not donate sperm for 6 months after my last treatment dose.I am not pregnant, not breastfeeding, and meet one of the required conditions.My blood clotting time is normal or slightly above, unless I'm on blood thinners.I have not had an organ transplant, Gilbert's disease, or treatments that could interfere with specific cancer drugs.I am not participating in any other clinical trials before my bladder surgery.I do not have active inflammatory bowel disease or a recent GI perforation.I am a woman of childbearing potential and my recent pregnancy test was positive.My cancer has spread to a lymph node in my pelvis but it can be removed with surgery.My bladder cancer diagnosis was confirmed through a biopsy or by doctors agreeing.Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L.I agree to have surgery aimed at curing my condition.My blood clotting time is normal or I am on blood thinners.My cancer has a neuroendocrine or small cell component.I do not have cancer in the upper part of my urinary tract.My kidney function, measured by creatinine levels, is within the normal range.I haven't had cancer treatment or been part of a cancer study in the last 4 weeks.My cancer is advanced and cannot be removed by surgery, or it has spread to other parts of my body.My bladder cancer has not spread, confirmed by CT or MRI scans.Your AST and ALT levels in your blood should not be more than 2.5 times the upper limit of normal.My doctor thinks I am not fit for certain bladder cancer surgeries.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sacituzumab govitecan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators actively looking for new participants in this research?
"No, this particular clinical trial is not looking for new participants. Although, it should be noted that the last update on clinicaltrials.gov was on 10/26/2022 and the original posting date was 11/1/2022. There are other 329 trials actively recruiting patients right now."
Answered by AI
What is the FDA's opinion of sacituzumab govitecan as a treatment?
"While there is some data to support the safety of this treatment, as it is only in Phase 2 trials, there is not yet any evidence for its efficacy. Therefore, our team has given it a score of 2."
Answered by AI
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