RecruitingPhase 2NCT06682728

Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence

Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence


Sponsor

University of California, Irvine

Enrollment

23 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — sacituzumab govitecan (an antibody-drug conjugate that delivers chemotherapy directly to cancer cells) and nivolumab (an immunotherapy) — after surgery for muscle-invasive bladder or urinary tract cancer with a high risk of returning. **You may be eligible if...** - You are 18 or older and have confirmed muscle-invasive urothelial cancer (bladder, ureter, or kidney pelvis) - You recently had curative surgery (radical cystectomy or nephroureterectomy) within the last 6 months - Your scans show no remaining cancer after surgery - You are in good physical condition (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has already spread to other organs - You have previously received certain immunotherapy drugs (PD-1/PD-L1 inhibitors) or sacituzumab govitecan before surgery - You have significant immune-related conditions or serious organ problems 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 (SG)

Given IV

DRUGNivolumab

Given IV


Locations(1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

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NCT06682728


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