RecruitingPhase 2NCT06161532

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 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


Sponsor

National Cancer Institute (NCI)

Enrollment

60 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a checkpoint immunotherapy drug (atezolizumab) to an antibody-drug therapy (sacituzumab govitecan) helps treat certain bladder or urothelial cancers that have already received prior treatment, including immunotherapy. It looks at two groups: those who previously received immunotherapy and those who did not. **You may be eligible if...** - You are 18 or older with advanced or metastatic urothelial (bladder/urinary tract) cancer - Your cancer has progressed after at least one prior line of therapy - You have acceptable organ function and general health (ECOG 0–2) - Your tumor has been confirmed by tissue biopsy **You may NOT be eligible if...** - You have active brain metastases requiring treatment - You have significant autoimmune disease requiring systemic treatment - You have had prior sacituzumab govitecan treatment - You are pregnant or breastfeeding - You have severe lung or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan

Sacituzumab govitecan is administered IV at 10 mg/kg on days 1 and 8 of each 21-day cycle.

DRUGAtezolizumab

Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06161532


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