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NCT06161532 · ClinicalTrials.gov registry record · Phase 2
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...
A Phase 2 study of Small Cell Carcinoma of the Bladder and Squamous Cell Carcinoma of the Bladder, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06161532: Recruiting Phase 2 study of Small Cell Carcinoma of the Bladder and Squamous Cell Carcinoma of the Bladder, sponsored by National Cancer Institute (NCI).
NCT06161532 is a Phase 2 study of Small Cell Carcinoma of the Bladder and Squamous Cell Carcinoma of the Bladder that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06161532, a Phase 2 study of Small Cell Carcinoma of the Bladder and Squamous Cell Carcinoma of the Bladder, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Percentage of participants by best overall response (e.g., CR, PR, SD, PD) to therapy
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Atezolizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 2 |
What NCT06161532 shows while recruiting
NCT06161532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 8 conditions, with Small Cell Carcinoma of the Bladder appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab govitecan is the first listed.
NCT06161532 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06161532 about?
NCT06161532 is a clinical study titled "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...". 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 t...
What is the current status of trial NCT06161532?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-08-01. Estimated completion is 2028-11-01.
What conditions does trial NCT06161532 study?
This clinical trial studies the following conditions: Small Cell Carcinoma of the Bladder, Squamous Cell Carcinoma of the Bladder, Renal Medullary Carcinoma, Small Cell Carcinoma of the Urinary Tract, Squamous Cell Carcinoma of the Urinary Tract.
What interventions are being tested in trial NCT06161532?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT06161532?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06161532 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06161532's enrollment target sits among peer trials
60 1027th of 2000 higher than 869 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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