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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06682728
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan (SG) — DRUG
    Given IV
  • Nivolumab — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 15, 2024
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan PLUS Nivolumab
    Patients eligible for this study treatment will receive combination therapy with Sacituzumab Govitecan with Nivolumab for 4 cycles, followed by single-agent Nivolumab for an additional 11 cycles.

Primary Outcome Measure

Primary Objective [ Time Frame: 6 months after last patient enrollment ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Nataliya Mar, MD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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