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...
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci w wieku 18 lat lub starsi z potwierdzonym rozpoznaniem rzadkiego nowotworu dróg moczowo-płciowych (nie raka prostaty), w zaawansowanym stadium lub z przerzutami.
- •Rodzaje nowotworów to m.in.: rak neuroendokrynny pęcherza lub dróg moczowych, rak płaskonabłonkowy pęcherza lub dróg moczowych, rak gruczołowy pęcherza, rak rdzeniasty nerki, rak płaskonabłonkowy prącia.
- •Dostępność tkanki nowotworowej do badań (może być konieczna nowa biopsja).
- •Pacjenci, którzy wcześniej byli leczeni lekami immunoterapii (ICI) lub nie mogą ich przyjmować (grupa A), albo pacjenci, którzy nie byli leczeni immunoterapią, ale kwalifikują się do niej (grupa B).
- •Stan ogólny pacjenta pozwalający na uczestnictwo w badaniu ( ECOG 0-1).
- •Dobre wyniki badań krwi i moczu, wskazujące na prawidłowe działanie narządów (wątroby, nerek, szpiku).
✗ Disqualifies
- •Pacjenci z rakiem prostaty.
- •Pacjenci z chorobami, które mogą wpływać na bezpieczeństwo lub skuteczność leczenia.
- •Pacjenci, którzy niedawno przeszli inne leczenie przeciwnowotworowe lub szczepienie.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 120 Years
- Last updated (source)
- July 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
Tzu-Fang Wang, R.N.
Andrea B Apolo, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.