Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma

Sponsor
YULISU
Study ID
NCT05160285
Phase
PHASE2
Status
Unknown

Conditions

  • Upper Urinary Tract Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 100 MG in 10 ML Injection — DRUG
    If you meet all the conditions to participate in the trial, you will receive the following treatments: Your physician will give you 360 mg of Nivolumab as an intravenous infusion every 3 weeks for about 30 minutes. For safety reasons, we recommend that you stay in the hospital for 60 minutes after the initial infusion of nivolumab. There will be a total of 3 cycles of Nivolumab treatments during the study period. You will need to return every 3 weeks. Each return will collect about 50 ml (10 tsp) of blood samples, depending on local standards.

Study Details

The aim of this study is to explore efficacy and safety of neoadjuvant nivolumab for non-metastatic upper tract urothelial carcinoma (UTUC), and explore the potential predictive biomarkers of immunotherapy.

Key Dates

Start date
Dec 25, 2020
Status verified
Dec 2021
Primary completion
Dec 15, 2023
Completion
Dec 30, 2024

Study Design

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

Arms

  • Experimental: Neoadjuvant nivolumab treatment arm
    Nivolumab 360mg intravenous adminstration every 3 weeks

Primary Outcome Measure

pathologic complete response rate (pCR) [ Time Frame: 1 month post neoadjuvant nivolumab and surgery ]

Central Contacts

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