Trials Sponsors Conditions Drugs Pricing

Conditions

muscle-invasive bladder cancer Muscle-invasive Urothelial Carcinoma of the Bladder

Outcome Measures

Primary Outcomes (1)

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.
36 months

Secondary Outcomes (3)

Pathological response-rate,
Upon completion of the study up to 40 months
Bladder-intact event-free survival (BI-EFS);
Up to 6 months
Overall survival
Up to 40 months

Study Arms (1)

Single Arm

OTHER

Single Arm treatment

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

Interventions

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).

Single Arm

Trodelvy 200 mg powder for concentrate for solution for infusionType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
KEYTRUDA 25 mg/mL concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

KEYTRUDA 25 mg/mL concentrate for solution for infusion
Named ingredient: pembrolizumab
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Ospedale San Raffaele S.r.l.
Type not reportedlead
Claudia Guerrieri
Otherlead

Study Sites (1)

Fondazione San Raffaele

Milan, MI, 20132, Italy

Related Publications (1)

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.
PMID: 41771275DERIVED

Study Officials

Andrea Necchi
Ospedale San Raffaele
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Sponsor delegated

Study Record Dates

First Submitted

August 9, 2022

First Posted

September 10, 2022

Study Start

September 20, 2023

Actual (reported)

Primary Completion

February 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

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.
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.
+12 more criteria

Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Single Arm

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Single Arm

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations