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Sacituzumab Govitecan and Atezolizumab Treatment for Rare Genitourinary Tumors

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Study Aim

This phase 2 study aims to evaluate the response rate to Sacituzumab Govitecan and Atezolizumab treatment in individuals with rare genitourinary tumors.

What is being tested

Sacituzumab govitecan

+ Atezolizumab

Drug
Who is being recruted

Carcinoma+2

+ Carcinoma, Transitional Cell

+ Neoplasms

From 18 to 120 Years
+38 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Study ContactTzu-Fang Wang, R.N.More contacts
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding better treatment options for people with rare types of genitourinary (GU) cancers, including certain aggressive bladder, urinary tract, kidney, and penile cancers. These rare cancers often have a more severe progression and lack established treatments, making them challenging to manage. The study investigates the effectiveness of a drug called sacituzumab govitecan (SG), used alone or together with another drug, atezolizumab, in patients who have these specific types of cancers. The trial aims to improve the response rate to these treatments, potentially offering new hope for patients with these difficult-to-treat conditions. Participants in the study must be adults with advanced or metastatic forms of these rare cancers. The study administers the treatments intravenously; SG is given on the first and eighth day of each 21-day cycle, while atezolizumab is given on the first day of each cycle. Participants who have not previously received certain types of immunotherapy may receive both drugs. The study will continue to treat participants until their cancer shows signs of progression or they experience severe side effects, for up to five years. This research could lead to more effective therapies for these rare and aggressive cancers, potentially improving outcomes for those affected.

Official TitleA Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer
NCT06161532
Principal SponsorNational Cancer Institute (NCI)
Study ContactTzu-Fang Wang, R.N.More contacts
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Transitional CellNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Criteria

23 inclusion criteria required to participate
Age \>= 18 years.

Participants must have histologically confirmed diagnosis of a locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor of the following histologies: * HGNEC, including, but not limited to, small cell carcinoma and large cell neuroendocrine carcinoma of the bladder or urinary tract * Squamous cell carcinoma of the bladder or urinary tract * Primary adenocarcinoma of the bladder or urinary tract (urachal or non-urachal) * Renal medullary carcinoma * Squamous cell carcinoma of the penis Note: For the purposes of enrollment, the urinary tract is defined as the renal pelvis, ureter, bladder, and urethra.

Pre-study treatment tissue availability (sufficient tissue for approximately 25 unstained slides is mandatory for enrollment. If tissue is determined to be insufficient/unsuitable, a fresh biopsy prior to study therapy will be required.

Locally advanced unresectable or metastatic disease. Participants who have received prior treatment must have evidence of progressive disease (PD; i.e., defined as new or progressive lesions evident on cross-sectional imaging).

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15 exclusion criteria prevent from participating
Prior treatment with immune checkpoint blockade therapies, including anti-PD-1, and anti-PD-L1 therapeutic antibodies (for Arm 2 only).

History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38, irinotecan, or atezolizumab, or hypersensitivity to Chinese hamster ovary cell products.

Symptomatic or untreated brain/CNS metastases.

Positive serum or urine Beta-human chorionic gonadotropin (Beta-hCG) test at screening.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment with sacituzumab govitecan

Group II

Experimental
Treatment with sacituzumab govitecan and atezolizumab

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center