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Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma

NCT05160285 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-12-16

No results posted yet for this study

Summary

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.

Conditions

  • Upper Urinary Tract Urothelial Carcinoma

Interventions

DRUG

Nivolumab 100 MG in 10 ML Injection

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.

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • YULISU

    lead OTHER

Principal Investigators

  • Yu-Li Su, MD · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-25
Primary Completion
2023-12-15
Completion
2024-12-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05160285 on ClinicalTrials.gov