Actively Recruiting
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 C...
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
60
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU. Objective: To test SG, either alone or combined with atezolizumab, in people with rare GU tumors. Eligibility: Adults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor. Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm. All participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle. Blood and urine tests, imaging scans, and other exams will be repeated during study visits. Treatment may continue for up to 5 years. Follow-up visits will continue for 5 more years.
CONDITIONS
Official Title
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 C...
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed locally advanced unresectable or metastatic non-prostate genitourinary tumor of these types: high grade neuroendocrine carcinomas (including small cell or large cell), squamous cell carcinoma of bladder or urinary tract, primary adenocarcinoma of bladder or urinary tract, renal medullary carcinoma, or squamous cell carcinoma of the penis
- Pre-study treatment tissue available for testing or willingness to have a fresh biopsy
- Evidence of progressive disease on imaging if previously treated
- Prior treatment as specified for respective study cohorts
- Measurable disease by RECIST 1.1
- ECOG performance status 0 or 1
- Adequate organ and marrow function as detailed in the protocol
- Prior treatments allowed with specified washout periods
- Treated central nervous system lesions meeting study conditions
- Ability and willingness to use effective contraception if applicable
- Willingness to sign informed consent
You will not qualify if you...
- Severe allergic reactions to sacituzumab govitecan, SN-38, irinotecan, atezolizumab, or related compounds
- Symptomatic or untreated brain or central nervous system metastases
- Positive pregnancy test
- Unwillingness to accept blood transfusions
- For cohort receiving atezolizumab: active or history of autoimmune disease requiring treatment
- History of certain lung diseases or active pneumonitis
- Anticipation of major surgery during study
- Prior allogeneic stem cell or organ transplant
- Recent treatment with live vaccines
- Uncontrolled fluid build-up requiring frequent drainage
- Uncontrolled hypercalcemia
- Significant cardiovascular disease within last 3 months
- Prior immune checkpoint therapy for cohort receiving atezolizumab
- Prior malignancy within 2 years except certain treated cancers
- History of leptomeningeal disease
- Active tuberculosis
- Severe uncontrolled illness limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Tzu-Fang Wang, R.N.
CONTACT
A
Andrea B Apolo, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here