Urothelial CarcinomaPhase 2NCT05226117
Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer
A Phase 2 study testing Sacituzumab govitecan in people with Urothelial Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Sacituzumab govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2022to 24 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Female or male subjects, >18 years of age, able to understand and give written informed consent
- Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
- Fit and planned for RC (according to local guidelines).
- ECOG performance status score of 0 or 1
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, absolute neutrophil count≥ 1,500/ mm3, and Platelets ≥ 100,000/ μL)
- Adequate hepatic function (Bilirubin ≤ 1.5 IULN, aspartate aminotransferase and alanine aminotransferase≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin >3 g/dl)
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- Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, and must not be lactating. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >2 years
- Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study therapy.
- Clinical stage defining clinical T2-T4N0M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1).
- The patient accepts to undergo radical cystectomy.
- Ineligibility to receive cisplatin-based neoadjuvant chemotherapy based on Galsky's criteria OR refusal to receive neoadjuvant cisplatin-based chemotherapy.
Who cannot join
- Have received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
- Have received prior radiotherapy on the bladder tumor.
- Refusal to undergo RC.
- Are 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 treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Have a known additional malignancy that is progressing or has required active treatment within the past 3 years.
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- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer defined as follows are not excluded; Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen (PSA) < 10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation. Women who are pregnant or lactating
- Have severe hypersensitivity (≥Grade 3) to sacituzumab govitecan and/or any of its excipients.
- Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Have nephrostomy, central venous catheters, any other types of catheters that could make the patient at higher risk of developing severe infectious complications during treatment with sacituzumab govitecan.
- Have ≥3 risk factors for the development of febrile neutropenia according to the ASCO guidelines (Smith et al, J Clin Oncol. 2015;33:3199-3212). These risk factors are the following: Age >65 years, advanced disease, Previous chemotherapy or radiation therapy, Preexisting neutropenia or bone marrow involvement with tumor, infection, Open wounds or recent surgery, Poor performance status or poor nutritional status, Poor renal function, Liver dysfunction, most notably elevated bilirubin, Cardiovascular disease, Multiple comorbid conditions, HIV infection.
- Have a history of inflammatory bowel disease, ulcerative colitis, or any other pre-existing inflammatory or autoimmune disease that could make the patient at higher risk of developing severe diarrhea or related complications.
- Have active cardiac disease, defined as:
- Myocardial infarction or unstable angina pectoris within 6 months of C1D1
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
- NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%
- Have a known history of HIV-1/2.
- Have active Hepatitis B virus (HBV) or Hepatitis C Virus (HCV). In subjects with a history of HBV or HCV, subjects with detectable viral loads will be excluded.
- Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SURE-01_An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Sacituzumab Govitecan, Before Radical Cystectomy, for Patients With Muscleinvasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy
SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).
Read the detailed description
SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).
The general framework of the study will be as follows:
A transurethral resection of the bladder tumor (TURBT) for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. With the aim to improve the sensitivity of computed tomography (CT) scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, CT scan, 18F-fluorodeoxyglucose positron emission tomography (18FDG-PET)/CT scan, and multiparametric bladder magnetic resonance imaging (mpMRI) will be done during screening and before cystectomy to stage and evaluate response.
- Eligible patients will receive neoadjuvant treatment: 7.5 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle.
- A total of 4 cycles is planned before surgery. Surgery will be planned at the time of study inclusion to be done within 4 weeks of the last dose of study drug. After surgery patients will be managed according to local guidelines which mirror the current EAU guidelines.
- Conditions
- Urothelial Carcinoma
- Being tested
- Sacituzumab govitecan
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecanDrug
Sacituzumab govitecan is a humanized monoclonal antibody (mAb) with a hydrolyzable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors while reducing systemic toxicity. SN-38 is the active metabolite of irinotecan. Sacituzumab govitecan is administered at 7.5 mg/kg as an IV infusion on days 1 and 8 of a 21- day cycle till progression, toxicity or withdrawal of consent
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients with muscle-invasive urothelial carcinoma of the bladder, who are suited for and accept radical cystectomy (RC) Receives: Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Pathological complete response will be defined as the absence of any residual viable tumor in the radical cystectomy specimen. Two independent pathologists, blinded to the study findings, with >10 years of experience in genitourinary tumors will independently evaluate the response. The pathological response assessment will be centralized and externally reviewed at San Raffaele Hospital and Scientific Institute, Milan, Italy.
Measured: After the last cycle of the investigational drug (each cycle is 21 days)
Secondary outcomes (3)
Radiological response
Radiological response on those patients with measurable disease will be evaluated by CT scans with contrast of chest/abdomen/pelvis, with a whole body fluorodeoxyglucose positron emission tomography, and with a multiparametric MRI of the bladder. RECIST v1.1 criteria will be used to assess patient the radiological response to treatment.
Measured: At baseline and within 2 weeks after the last cycle of the investigational drug (each cycle is 21 days)
Perioperative outcomes
Perioperative outcomes will be systematically and prospectively collected at surgery and during hospitalization, as well as at 30- and 90-day after surgery during patient interviews done by medical doctors and according to the EAU guidelines on reporting and grading of complications, as previously reported by our group within the PURE-01 study (Briganti A, et al. Eur Urol 2020;77:576-580).
Measured: During hospitalization for the surgery and at 30- and 90-day after surgery
Survival outcomes
Overall survival
Measured: At the end of study, an average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start23 Mar 2022
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- High Research
- Responsible party
- Principal investigator, Prof. Andrea Necchi, IRCCS San Raffaele
- Investigators
- Andrea Necchi, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226117
- Sponsor's protocol ID
- SURE-01
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Necchi A, de Jong JJ, Maiorano BA, Proudfoot JA, Basile G, Cigliola A, Mercinelli C, Tateo V, Piacentini M, Crupi E, Pastorino GL, Latini G, Tomasi E, Davicioni E, Moschini M, Brembilla G, Colecchia M, de Cobelli F, Ross JS, Madison R, Tambaoan CFB, Briganti A, Montorsi F. Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01 Trial. J Clin Oncol. 2026 Jul 20;44(21):2017-2028. doi: 10.1200/JCO-26-00142. Epub 2026 May 31.
PubMed 42218654
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURE-01_An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Sacituzumab Govitecan, Before Radical Cystectomy, for Patients With Muscleinvasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT05226117
- Acronym / sponsor ID
- SURE-01
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- High Research
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).
Detailed description
SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).
The general framework of the study will be as follows:
A transurethral resection of the bladder tumor (TURBT) for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. With the aim to improve the sensitivity of computed tomography (CT) scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, CT scan, 18F-fluorodeoxyglucose positron emission tomography (18FDG-PET)/CT scan, and multiparametric bladder magnetic resonance imaging (mpMRI) will be done during screening and before cystectomy to stage and evaluate response.
- Eligible patients will receive neoadjuvant treatment: 7.5 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle.
- A total of 4 cycles is planned before surgery. Surgery will be planned at the time of study inclusion to be done within 4 weeks of the last dose of study drug. After surgery patients will be managed according to local guidelines which mirror the current EAU guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Sacituzumab govitecanPatients with muscle-invasive urothelial carcinoma of the bladder, who are suited for and accept radical cystectomy (RC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female or male subjects, >18 years of age, able to understand and give written informed consent
- Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
- Fit and planned for RC (according to local guidelines).
- ECOG performance status score of 0 or 1
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, absolute neutrophil count≥ 1,500/ mm3, and Platelets ≥ 100,000/ μL)
Key exclusion criteria (19 listed)
- Have received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
- Have received prior radiotherapy on the bladder tumor.
- Refusal to undergo RC.
- Are 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 treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab govitecanSacituzumab govitecan is a humanized monoclonal antibody (mAb) with a hydrolyzable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors while reducing systemic toxicity. SN-38 is the active metabolite of irinotecan. Sacituzumab govitecan is administered at 7.5 mg/kg as an IV infusion on days 1 and 8 of a 21- day cycle till progression, toxicity or withdrawal of consent | Drug | Treatment arm |
Primary outcome
Pathological complete response
Time frame: After the last cycle of the investigational drug (each cycle is 21 days)
Pathological complete response will be defined as the absence of any residual viable tumor in the radical cystectomy specimen. Two independent pathologists, blinded to the study findings, with >10 years of experience in genitourinary tumors will independently evaluate the response. The pathological response assessment will be centralized and externally reviewed at San Raffaele Hospital and Scientific Institute, Milan, Italy.
3 secondary outcomes
Radiological response
Time frame: At baseline and within 2 weeks after the last cycle of the investigational drug (each cycle is 21 days)
Perioperative outcomes
Time frame: During hospitalization for the surgery and at 30- and 90-day after surgery
Survival outcomes
Time frame: At the end of study, an average 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42218654Necchi A, de Jong JJ, Maiorano BA, Proudfoot JA, Basile G, Cigliola A, Mercinelli C, Tateo V, Piacentini M, Crupi E, Pastorino GL, Latini G, Tomasi E, Davicioni E, Moschini M, Brembilla G, Colecchia M, de Cobelli F, Ross JS, Madison R, Tambaoan CFB, Briganti A, Montorsi F. Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01 Trial. J Clin Oncol. 2026 Jul 20;44(21):2017-2028. doi: 10.1200/JCO-26-00142. Epub 2026 May 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Necchi, MD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab govitecan in people with Urothelial Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
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 13 inclusion and 19 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: finished, as of the sponsor's last update on 27 Mar 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathological complete response (time frame: After the last cycle of the investigational drug (each cycle is 21 days)). 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 NCT05226117, which also lists 1 linked publication.
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 Mar 2026.