← Back to Search

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

Must not have

Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial before radical cystectomy

Known history of active hepatitis B or active hepatitis C virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am 18 years old or older.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am considered a candidate for bladder removal and lymph node surgery by both my urologist and oncologist.

Select...

My cancer has spread to a lymph node in my pelvis but it can be removed with surgery.

Select...

My bladder cancer diagnosis was confirmed through a biopsy or by doctors agreeing.

Select...

I agree to have surgery aimed at curing my condition.

Select...

My blood clotting time is normal or I am on blood thinners.

Select...

My kidney function, measured by creatinine levels, is within the normal range.

Select...

My bladder cancer has not spread, confirmed by CT or MRI scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not participating in any other clinical trials before my bladder surgery.

Select...

I have an active hepatitis B or C infection.

Select...

I am currently on antibiotics for an infection.

Select...

I do not have active inflammatory bowel disease or a recent GI perforation.

Select...

My cancer has a neuroendocrine or small cell component.

Select...

I haven't had cancer treatment or been part of a cancer study in the last 4 weeks.

Select...

My cancer is advanced and cannot be removed by surgery, or it has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic complete response (pCR) rate

Secondary study objectives

Incidence of adverse events

Overall survival (OS)

Recurrence free survival (RFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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