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Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer

NCT03518320 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-08-27

No results posted yet for this study

Summary

The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) during an 84-day dosing cycle induction period comprised of four consecutive 21-day dosing cycles.

Conditions

  • Bladder Cancer TNM Staging Primary Tumor (T) T2
  • Bladder Cancer TNM Staging Primary Tumor (T) T2A
  • Bladder Cancer TNM Staging Primary Tumor (T) T2B
  • Bladder Cancer TNM Staging Primary Tumor (T) T3
  • Bladder Cancer TNM Staging Primary Tumor (T) T3A
  • Bladder Cancer TNM Staging Primary Tumor (T) T3B
  • Bladder Cancer TNM Staging Regional Lymph Node (N) N0
  • Bladder Cancer TNM Staging Regional Lymph Node (N) N1
  • Bladder Cancer TNM Staging Distant Metastasis (M) M0

Interventions

DRUG

Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

TAR-200 will be placed in the bladder through an inserter and gradually release gemcitabine for four consecutive 21-day dosing cycles for a total period of approximately 84 days

DRUG

Nivolumab Injection [Opdivo]

Nivolumab will be given intravenously on specified days for four consecutive 21-day dosing cycles for a total period of approximately 84 days

Sponsors & Collaborators

Principal Investigators

  • Christopher Cutie, MD · Taris Biomedical LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-12-11
Completion
2019-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03518320 on ClinicalTrials.gov