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

DRUG3 trials

Sponsors

Taris Biomedical LLC

Conditions

Bladder Cancer TNM Staging Distant Metastasis (M) M0Bladder Cancer TNM Staging Primary Tumor (T) T2Bladder Cancer TNM Staging Primary Tumor (T) T2ABladder Cancer TNM Staging Primary Tumor (T) T2BBladder Cancer TNM Staging Primary Tumor (T) T3Bladder Cancer TNM Staging Primary Tumor (T) T3ABladder Cancer TNM Staging Primary Tumor (T) T3BBladder Cancer TNM Staging Regional Lymph Node (N) N0

Phase 1

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

CompletedNCT02720367

Taris Biomedical LLCUrinary Bladder Cancer

Start: 2016-01-31End: 2020-03-31Updated: 2020-03-10

Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

CompletedNCT02722538

Taris Biomedical LLCUrinary Bladder Cancer

Start: 2016-05-31End: 2019-05-02Updated: 2023-09-18

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

TerminatedNCT03518320

Taris Biomedical LLCBladder Cancer TNM Staging Distant Metastasis (M) M0, Bladder Cancer TNM Staging Primary Tumor (T) T2, Bladder Cancer TNM Staging Primary Tumor (T) T2A +6

Start: 2019-01-02End: 2019-12-11Updated: 2024-08-27

Related Papers

The Safety, Tolerability, and Preliminary Efficacy of a Gemcitabine-releasing Intravesical System (TAR-200) in American Urological Association-defined Intermediate-risk Non-muscle-invasive Bladder Cancer Patients: A Phase 1b Study.

2024-02-1615 citations

Safety, tolerability, and preliminary efficacy of TAR-200 in patients with intermediate risk non–muscle-invasive bladder cancer: A phase 1 study.

Journal of Clinical Oncology2023-02-202 citations

The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial.

2022-04-1418 citations

Effect of GemRIS (gemcitabine-releasing intravesical system, TAR-200) on antitumor activity in muscle-invasive bladder cancer (MIBC).

Journal of Clinical Oncology2017-05-2015 citations