OncoMatch/Clinical Trials/NCT06161532
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...
Is NCT06161532 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sacituzumab govitecan and Atezolizumab for small cell carcinoma of the bladder.
Treatment: Sacituzumab govitecan · Atezolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Penile Carcinoma
Disease stage
Metastatic disease required
Grade: high grade (for neuroendocrine carcinomas)
locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — neoadjuvant, adjuvant, or first-line for locally advanced/metastatic
participants with HGNEC of the bladder/urinary tract cancer, whom must have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment in the locally advanced/metastatic setting
Cannot have received: immune checkpoint inhibitor
Exception: Cohort B only
Prior treatment with immune checkpoint blockade therapies, including anti-PD-1, and anti-PD-L1 therapeutic antibodies (for Arm 2 only)
Cannot have received: allogeneic stem cell or solid organ transplantation
Prior allogeneic stem cell or solid organ transplantation
Lab requirements
Blood counts
Hemoglobin >= 9.0 g/dL; ANC >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Serum creatinine <= 2 x ULN or creatinine clearance >= 30 ml/min/1.73 m^2 (or eGFR per institutional standard)
Liver function
Total bilirubin <= 1.5 x ULN (<= 3 x ULN in Gilbert's); AST/ALT <= 2.5 x ULN (<= 5 x ULN if liver mets); alkaline phosphatase <= 2.5 x ULN (<= 5 x ULN if liver or bone mets)
Adequate organ and marrow function as defined below: Hemoglobin (Hgb) >= 9.0 g/dL; ANC >= 1,500/mcL; Platelets >= 100,000/mcL; Total bilirubin <= 1.5 x ULN (<= 3 x ULN in Gilbert's); AST/ALT <= 2.5 x ULN (<= 5 x ULN if liver mets); Serum creatinine <= 2 x ULN or creatinine clearance >= 30 ml/min/1.73 m^2; Alkaline phosphatase <= 2.5 x ULN (<= 5 x ULN if liver or bone mets); Serum albumin >= 25g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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