AzTrials
AzTrials

Muscle Invasive Bladder CarcinomaPhase 2NCT05581589

Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer

A Phase 2 study testing Lymphadenectomy, Radical Cystectomy and Sacituzumab Govitecan in people with Muscle Invasive Bladder Carcinoma and Stage II Bladder Cancer AJCC v8, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial tests whether sacituzumab govitecan given before radical cystectomy works in treating patients with non-urothelial bladder cancer. Sacituzumab govitecan contains a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lymphadenectomy, Radical Cystectomy and Sacituzumab Govitecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
15 Jun 2023to 6 Mar 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be at least 18 years of age on the day of signing informed consent. Participant (or legally acceptable representative if applicable) provides written informed consent for trial
  • Participants must have either histologically or by clinical consensus (based on imaging and/or exam under anesthesia) confirmed diagnosis of muscle invasive bladder cancer (cT2-T4aN0-N1M0 or cT1-4aN1M0 clinical stage per American Joint Commission on Cancer [AJCC]). Patients with clinical node-positive (N1) stage are eligible provided the lymph node (LN) is confined to the true pelvis and is within the planned surgical LN dissection template; cN1 is defined as a lymph node with >= 15 mm short axis or biopsy-positive for carcinoma
  • Must have clinical non-metastatic bladder cancer (M0) determined by cross-sectional Computed tomography (CT) chest, abdomen and pelvis (CAP) or magnetic resonance imaging (MRI)
  • Review of pathology by local expert genitourinary (GU) pathologist is required. Any component (%) of non-conventional urothelial (variant histology) noted on transurethral resection of bladder tumour (TURBT) is allowed, for histologic types not listed below. However, for the variant histologic types listed below, the following parameters need to be met:
  • Squamous cell carcinoma / squamous cell features need to be pure or predominant (>= 1 variant histologic with total non-conventional urothelial component > 50%).
  • Adenocarcinoma / glandular features need to be pure or predominant (>= 1 variant histologic total non-conventional urothelial component > 50%).
Show all 26Show fewer
  • Any % of neuroendocrine / small cell histology is excluded.
  • Patients must be considered unfit for cisplatin based on the Galsky et al. criteria or refuse cisplatin despite adequate counseling in cisplatin-fit patients. Especially, for tumors containing squamous cell or glandular features, every effort should be made to discuss the benefit of neoadjuvant cisplatin-based chemotherapy shown in the S8710 trial
  • Participants must be deemed eligible for radical cystectomy (RC) and pelvic lymph node dissection (PLND) by both urologist and medical oncologist
  • TURBT that showed muscularis propria (or lamina propria for cT1N1 tumors) invasion should be within 12 weeks prior to beginning study therapy. Patients must have available tumor tissue from either initial or repeat TURBT, prior to starting study therapy. Archival and/or fresh tumor tissue sample of a tumor lesion (TURBT specimen) should be provided and must contain muscle invasive component, at least >= T2 tumor (for cT2 tumors), unless clinical stage is cT1N1M0 (in that case muscle invasive component is not necessary). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory, preferably within 14 days from the date slides are cut if possible. Patient must be willing to provide tumor tissue for research. Research samples will not be used for unrelated studies
  • A male participant must agree to use a contraception during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Patients with ECOG PS 2 may be permitted only after discussion with the trial primary investigator (PI) (Dr. Grivas). Evaluation of ECOG PS is to be performed within 7 days prior to the date of enrollment.
  • Absolute neutrophil count (ANC) >= 1500/uL (within 10 days prior to the start of study treatment)
  • Platelets >= 100 000/uL (within 10 days prior to the start of study treatment)
  • Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 10 days prior to the start of study treatment)
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks prior to study drug treatment
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 30 ml/min (glomular filtration rate [GFR] can be used in place of creatinine clearance; 24-hour urine collection can be used for more accurate estimate as needed) (within 10 days prior to the start of study treatment)
  • Creatinine clearance (CrCl) should be calculated per institutional standard
  • Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 10 days prior to the start of study treatment)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) =< 2.5 x ULN (within 10 days prior to the start of study treatment)
  • International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy (within 10 days prior to the start of study treatment)
  • Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy (within 10 days prior to the start of study treatment)
  • Patients must agree to undergo curative intent surgery.

Who cannot join

  • Patients with any % of neuroendocrine / small cell histology
  • Patients considered to be medically unfit for SG, TURBT or radical cystectomy (per investigator discretion)
  • Prior systemic anti-cancer therapy, including investigational agent/device within 4 weeks or prior radiation therapy within 2 weeks. Intravesical therapies are allowed without specified treatment interval
  • Known locally advanced (unresectable, e.g. cT4b) or metastatic (cN2-3, M1) cancer on baseline radiographic imaging (CT or MRI) obtained within 28 days prior to registration
  • Active infection requiring systemic antibiotic therapy at the time of trial initiation. Human immunodeficiency virus (HIV)-positive patients on active therapy are eligible as long as their viral load is undetectable and CD4 count is within normal parameters during the time of trial therapy initiation
  • Known history of active hepatitis B (defined as hepatitis B surface antigen [HBsAg] detected or positive hepatitis B virus [HBV] polymerase chain reaction [PCR] test) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] detected) infection. Note: no testing for hepatitis B and hepatitis C is required if there is no clinical suspicion of such infection
Show all 22Show fewer
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Known personality, psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
  • Patients may not have concurrent upper urinary tract (i.e., ureter, renal pelvis) invasive urothelial carcinoma. Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that have been definitively treated with at least one post-treatment disease assessment (i.e., cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible. Previously treated or concurrent non-invasive (Ta, Tis) urethra carcinoma is allowed, but history of or concurrent invasive urethra carcinoma is excluded
  • Patients may not have another malignancy that could interfere with the evaluation of safety or efficacy of of SG. Patients with prior malignancy will be allowed without PI approval in the following circumstances:
  • Not currently active and completed therapy at least 2 years prior to the date of registration.
  • Non-invasive cancer, such as low risk cervical cancer or any carcinoma in situ.
  • Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy), and in which no systemic chemotherapy was indicated (e.g., low/intermediate risk prostate cancer, non-melanoma skin cancer, etc.). Low/intermediate risk prostate cancer on active surveillance or watchful waiting is allowed. Other cancers not meeting these criteria must be discussed with trial PI (Dr. Grivas)
  • Patients may not have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury =< 3 weeks prior to starting SG, or who have not recovered from side effects of such procedure or injury
  • Have active (based on symptoms, endoscopic or biopsy findings) chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) at time of trial therapy initiation or history of GI perforation within 6 months of enrollment
  • Patients may not have clinically significant cardiac diseases, including any of the following:
  • History or presence of serious uncontrolled ventricular arrhythmias.
  • Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), New York Heart Association (NYHA) Class III or greater congestive heart failure (CHF) or left ventricular ejection fraction of < 40%, cerebrovascular accident (CVA), transient ischemic attack (TIA).
  • Patients unwilling or unable to comply with the protocol or with known allergy to SG, its analogues, or excipients in the various formulations
  • Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial before radical cystectomy
  • WOCBP with positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required for eligibility. Active lactation is exclusion
  • History of allogeneic solid visceral organ transplant, Gilbert's disease, prior systemic irinotecan or topotecan or other topoisomerase-1 inhibitor, or concomitant medications that significantly interfere with ABCA1 transporter or UGT1A1 with no alternate option available

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Pilot Single Arm Trial With Sacituzumab Govitecan as Neoadjuvant Therapy in Pts With Non-Urothelial Muscle Invasive Bladder Cancer

This phase II trial tests whether sacituzumab govitecan given before radical cystectomy works in treating patients with non-urothelial bladder cancer. Sacituzumab govitecan contains a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan before radical cystectomy may make the surgery more effective in patients with muscle invasive bladder cancer.

Read the detailed description

OUTLINE:

Patients receive sacituzumab govitecan intravenously (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.

After completion of study treatment, patients are followed up at 1-3 months after radical cystectomy and then every 3-6 months for 2 years.

Being tested
Lymphadenectomy, Radical Cystectomy, Sacituzumab Govitecan
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LymphadenectomyProcedure or surgery

    Also called excision of the lymph node, Lymph Node Dissection, Lymph Node Excision

    Undergo pelvic lymph node dissection

  • Radical CystectomyProcedure or surgery

    Also called Complete Cystectomy

    Undergo radical cystectomy

  • Sacituzumab GovitecanBiological

    Also called hRS7-SN38 Antibody Drug Conjugate, IMMU-132, RS7-SN38, Sacituzumab Govitecan-hziy

    Given IV

Study groups in NCT05581589
Study groupRoleWhat they receive
Treatment (sacituzumab govitecan)ExperimentalPatients 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.
Receives: Procedure: Lymphadenectomy; Procedure: Radical Cystectomy; Biological: Sacituzumab Govitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response (pCR Defined as ypT0N0)

    Percentage of patients with no histologic evidence of tumor at time of cystectomy (ypT0N0)

    Measured: At radical cystectomy (Radical cystectomy is expected to occur within 2-6 weeks after the last neoadjuvant trial therapy dose)

Secondary outcomes (5)

  1. Recurrence-free Survival at the 2-year Time Point

    Measured as the percentage of participants who are cancer recurrence-free at 2 years

    Measured: Up to 2 years from time of study enrollment

  2. Overall Survival (OS) at the 2-year Time Point

    Measured as the percentage of participants who are alive at 2 years

    Measured: Up to 2 years from time of study enrollment

  3. Frequency of Any Adverse Event According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) Related to Study Therapy.

    The frequency of toxicity of study therapy regimen. Measured as the number of participants who experienced an AE (any grade) related to study therapy while on trial.

    Measured: Up to 2 years from time of study enrollment

  4. Frequency of Grade 3 or Greater Adverse Events According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) Related to Study Therapy.

    The severity of toxicity of therapy regimen. Measured as the number of participants who experienced an AE of grade 3 or higher related to study therapy while on trial

    Measured: Up to 2 years from time of study enrollment

  5. Pathologic Downstaging to <ypT2N0 at Time of Radical Cystectomy

    To assess the percentage of patients who had pathologic downstaging to <ypT2N0 stage at time of radical cystectomy

    Measured: At radical cystectomy (radical cystectomy occured within 6 weeks after the last neoadjuvant trial therapy dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start15 Jun 2023
  3. Primary completion15 Oct 2024
  4. Study completion6 Mar 2026

Why it stopped: Study closed to accrual before meeting accrual goal due to major enrollment challenges based on the very rare disease indication studied and rapid changes in the therapy landscape.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581589
Sponsor's protocol ID
RG1122399
Other IDs
NCI-2022-04528, 10996
Status last verified
Apr 2026
First submitted
6 Oct 2022
Last updated
27 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lymphadenectomy, Radical Cystectomy and Sacituzumab Govitecan in people with Muscle Invasive Bladder Carcinoma and Stage II Bladder Cancer AJCC v8, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR Defined as ypT0N0) (time frame: At radical cystectomy (Radical cystectomy is expected to occur within 2-6 weeks after the last neoadjuvant trial therapy dose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in