Muscle-invasive Urothelial Carcinoma of the BladderPhase 2SURE-02NCT05535218
Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer
A Phase 2 study testing Sacituzumab govitecan is a humanized mAb with a hydrolysable 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, whi in people with Muscle-invasive Urothelial Carcinoma of the Bladder, run by Claudia Guerrieri at 1 site in Italy.
Trial summary
This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy. 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
- Muscle-invasive Urothelial Carcinoma of the Bladder
- What is being tested?
- Sacituzumab govitecan is a humanized mAb with a hydrolysable 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, whi
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2023to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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.
- Refusal of unsuitability for standard chemoradiotherapy protocols.
- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, ANC ≥ 1,500/ mm3, and Platelets
Show all 15Show fewer
- ≥ 100,000/ μL)
- Adequate hepatic function (Bilirubin ≤ 1.5 IULN, AST and ALT ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin >3 g/dl)
- 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 T2-T3bN0M0 MIBC, assessed by CT + PET/CT + pelvic MRI.
- The patient accepts to undergo RC.
- 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.
- Have received a partial cystectomy.
- Refusal to undergo RC.
- Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella,varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Have received any antibiotics within 30 days prior to the first dose of study drug.
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- 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 investigationalagent.
- Have a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- 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.
- Have severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of its excipients.
- Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- 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 woundsor 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 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 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 known history of HIV-1/2 infection.
- Have a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- 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.
- High dose systemic corticosteroids (≥20 mg of prednisolone or its equivalent) are not allowed within 2 weeks of C1D1.
- Have received or are currently receiving (within the previous 2 weeks) antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SURE-02_An Open Label, Single-arm, Phase 2 Study of Perioperative Pembrolizumab Plus Sacituzumab Govitecan, and Bladder-saving Approach, for Patients With Muscle-invasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy
This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.
Patients will be consecutively enrolled and treated. All patients enrolled who receive at least 1 cycle of study drug will be included in the primary and secondary endpoint analyses.
Read the detailed description
The general framework of the study will be as follows:
A TURBT for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, computed tomography (CT) scan, 18FDG-PET/CT scan, and a pelvic MRI will be done during screening and before the surgical assessment to stage and evaluate response. The same imaging assessments will be performed after the neoadjuvant treatment. Patients with the evidence of no detectable disease after neoadjuvant therapy will also undergo a cystoscopy assessment prior to the reTURBT.
- Eligible patients will receive neoadjuvant treatment: 7.5 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle.
- Pembrolizumab will be administered in combination with sacituzumab govitecan on day 1, every 21 days, at the standard dose of 200 mg intravenously.
- A total of 4 cycles is planned before surgery.
- Patients who achieve a clinical complete response (cCR) will be offered a reTURBT instead of radical cystectomy. Patients not achieving a cCR will undergo a radical cystectomy.
- cCR will be defined as the achievement of ALL the following requirements: no evidence of residual disease (VIRADS 0 score) at MRI, negative cystoscopy, and a biopsy obtained via reTURBT revealing no residual viable cancer.
- Surgery will be planned at the time of study inclusion to be done ideally within 4 weeks of the last dose of study drug, and not later than 12 weeks from the last dose of study drug.
- After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab(neoadjuvant + adjuvant).
- After cystectomy or reTURBT, patients will undergo imagingassessments according to EAU guidelines. In patients undergoing reTURBT, cystoscopy assessments will be performed every 4 months for the first 2 years (until study conclusion),then according to investigator judgment.
- At the end of the adjuvant period, patients will enter the follow-up period which will lastuntil 12 months from the last dose of pembrolizumab.
- Being tested
- Sacituzumab govitecan is a humanized mAb with a hydrolysable 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, whi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecan is a humanized mAb with a hydrolysable 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, whiDrug
Neoadjuvant treatment: 7,5mg/kg sacituzumab-govitecan IV, on days 1, 8, of each 21 day cycle; Pembrolizumab will be administered in combination with sacituzumab-govitecan on day 1, every 21 days, at the standard dose of 200 mg intravenously. A total of 4 cycles is planned before surgery.
After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab (neoadjuvant + adjuvant).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single Arm treatment Receives: Drug: Sacituzumab govitecan is a humanized mAb with a hydrolysable 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, whi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical CR-rate
To assess whether sacituzumab govitecan plus pembrolizumab is an effective perioperative strategy in patients with clinical T2-3bN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.
Measured: 36 months
Secondary outcomes (3)
Pathological response-rate,
To evaluate the proportion of patients who will be pathological responders.
Measured: Upon completion of the study up to 40 months
Bladder-intact event-free survival (BI-EFS);
To evaluate the surgical and medical safety of neoadjuvant combination therapy, as well as of the adjuvant pembrolizumab therapy.
Measured: Up to 6 months
Overall survival
To assess survival outcomes (event-free survival and overall survival), in the total population and in the subgroups according to the pathological response.
Measured: Up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start20 Sep 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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 Muscle-invasive Urothelial Carcinoma of the BladderStudies of the same condition, open and under way.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Guerrieri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Guerrieri, Ospedale San Raffaele
- Investigators
- Andrea Necchi, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535218
- Sponsor's protocol ID
- SURE-02
- Other IDs
- 2024-514569-20-00
- Acronym
- SURE-02
- Status last verified
- Mar 2025
- First submitted
- 9 Aug 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Necchi A, Maiorano BA, de Jong JJ, Proudfoot JA, Basile G, Cigliola A, Mercinelli C, Tateo V, Piacentini M, Pastorino G, Latini G, Tomasi E, Davicioni E, Moschini M, Brembilla G, Colecchia M, de Cobelli F, Briganti A, Ross JS, Pavlick DC, Montorsi F. Neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by adjuvant pembrolizumab, in patients with muscle-invasive bladder cancer (SURE-02): a single-arm, phase 2 study. Lancet Oncol. 2026 Apr;27(4):442-451. doi: 10.1016/S1470-2045(26)00050-1. Epub 2026 Feb 27.
PubMed 41771275
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURE-02_An Open Label, Single-arm, Phase 2 Study of Perioperative Pembrolizumab Plus Sacituzumab Govitecan, and Bladder-saving Approach, for Patients With Muscle-invasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT05535218
- Acronym / sponsor ID
- SURE-02 / SURE-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Claudia GuerrieriUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Sep 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.
This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.
Patients will be consecutively enrolled and treated. All patients enrolled who receive at least 1 cycle of study drug will be included in the primary and secondary endpoint analyses.
Detailed description
The general framework of the study will be as follows:
A TURBT for biopsy, histological characterization, and local staging will be executed first, according to the guidelines. With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor, computed tomography (CT) scan, 18FDG-PET/CT scan, and a pelvic MRI will be done during screening and before the surgical assessment to stage and evaluate response. The same imaging assessments will be performed after the neoadjuvant treatment. Patients with the evidence of no detectable disease after neoadjuvant therapy will also undergo a cystoscopy assessment prior to the reTURBT.
- Eligible patients will receive neoadjuvant treatment: 7.5 mg/kg sacituzumab govitecan IV, on days 1, 8, of each 21 day cycle.
- Pembrolizumab will be administered in combination with sacituzumab govitecan on day 1, every 21 days, at the standard dose of 200 mg intravenously.
- A total of 4 cycles is planned before surgery.
- Patients who achieve a clinical complete response (cCR) will be offered a reTURBT instead of radical cystectomy. Patients not achieving a cCR will undergo a radical cystectomy.
- cCR will be defined as the achievement of ALL the following requirements: no evidence of residual disease (VIRADS 0 score) at MRI, negative cystoscopy, and a biopsy obtained via reTURBT revealing no residual viable cancer.
- Surgery will be planned at the time of study inclusion to be done ideally within 4 weeks of the last dose of study drug, and not later than 12 weeks from the last dose of study drug.
- After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab(neoadjuvant + adjuvant).
- After cystectomy or reTURBT, patients will undergo imagingassessments according to EAU guidelines. In patients undergoing reTURBT, cystoscopy assessments will be performed every 4 months for the first 2 years (until study conclusion),then according to investigator judgment.
- At the end of the adjuvant period, patients will enter the follow-up period which will lastuntil 12 months from the last dose of pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: Sacituzumab govitecan is a humanized mAb with a hydrolysable 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, whiSingle Arm treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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.
- Refusal of unsuitability for standard chemoradiotherapy protocols.
Key exclusion criteria (27 listed)
- Have received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
- Have received prior radiotherapy on the bladder tumor.
- Have received a partial cystectomy.
- Refusal to undergo RC.
- Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella,varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
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 govitecan is a humanized mAb with a hydrolysable 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, whiNeoadjuvant treatment: 7,5mg/kg sacituzumab-govitecan IV, on days 1, 8, of each 21 day cycle; Pembrolizumab will be administered in combination with sacituzumab-govitecan on day 1, every 21 days, at the standard dose of 200 mg intravenously. A total of 4 cycles is planned before surgery. After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab (neoadjuvant + adjuvant). | Drug | Single Arm |
Primary outcome
Clinical CR-rate
Time frame: 36 months
To assess whether sacituzumab govitecan plus pembrolizumab is an effective perioperative strategy in patients with clinical T2-3bN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.
3 secondary outcomes
Pathological response-rate,
Time frame: Upon completion of the study up to 40 months
Bladder-intact event-free survival (BI-EFS);
Time frame: Up to 6 months
Overall survival
Time frame: Up to 40 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 41771275Necchi A, Maiorano BA, de Jong JJ, Proudfoot JA, Basile G, Cigliola A, Mercinelli C, Tateo V, Piacentini M, Pastorino G, Latini G, Tomasi E, Davicioni E, Moschini M, Brembilla G, Colecchia M, de Cobelli F, Briganti A, Ross JS, Pavlick DC, Montorsi F. Neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by adjuvant pembrolizumab, in patients with muscle-invasive bladder cancer (SURE-02): a single-arm, phase 2 study. Lancet Oncol. 2026 Apr;27(4):442-451. doi: 10.1016/S1470-2045(26)00050-1. Epub 2026 Feb 27.
- 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 principal investigator
Ospedale 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 is a humanized mAb with a hydrolysable 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, whi in people with Muscle-invasive Urothelial Carcinoma of the Bladder, run by Claudia Guerrieri 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 15 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical CR-rate (time frame: 36 months). 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 NCT05535218, 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 2 Apr 2025.