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...

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06161532
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Adenocarcinoma of the Bladder
  • Primary Adenocarcinoma of the Urinary Tract
  • Renal Medullary Carcinoma
  • Small Cell Carcinoma of the Bladder
  • Small Cell Carcinoma of the Urinary Tract
  • Squamous Cell Carcinoma of the Bladder
  • Squamous Cell Carcinoma of the Penis
  • Squamous Cell Carcinoma of the Urinary Tract

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab govitecan — DRUG
    Sacituzumab govitecan is administered IV at 10 mg/kg on days 1 and 8 of each 21-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jun 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Treatment with sacituzumab govitecan
  • Experimental: Arm 2
    Treatment with sacituzumab govitecan and atezolizumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: On days 1 and 8 of each cycle and at every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Tzu-Fang Wang, B.S.N.
[email protected]
240-858-3236

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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