At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed locally advanced unresectable or metastatic non-prostate GU tumor of specified histologies (HGNEC, squamous cell carcinoma bladder/urinary tract, primary adenocarcinoma bladder/urinary tract, renal medullary carcinoma, squamous cell carcinoma penis)
- ✓Pre-study treatment tissue availability with sufficient tissue for approximately 25 unstained slides mandatory; fresh biopsy required if insufficient
- ✓Evidence of progressive disease on imaging if prior treatment received
- ✓Cohort A: prior ICI (PD-1 or PD-L1) or ICI ineligible; Cohort B: ICI naive but eligible
- ✕History of severe hypersensitivity or allergic reactions to SG, SN-38, irinotecan, atezolizumab, or Chinese hamster ovary cell products
- ✕Symptomatic or untreated brain/CNS metastases
- ✕Positive serum or urine Beta-hCG at screening
- ✕Unwilling to accept blood products as medically indicated
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 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
In Brief
A Phase 2 clinical trial evaluating Sacituzumab govitecan and Atezolizumab for Small Cell Carcinoma of the Bladder and 7 related conditions. Currently recruiting, targeting 60 participants across 1 site.
Detailed 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. ...
Study Details
Timeline
Arms & Interventions
Treatment with sacituzumab govitecan
Treatment with sacituzumab govitecan and atezolizumab
Interventions
Sacituzumab govitecan is administered IV at 10 mg/kg on days 1 and 8 of each 21-day cycle.
Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.