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

Conditions

• Bladder Cancer TNM Staging Distant Metastasis (M) M0
• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 — DRUG
  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
• Nivolumab Injection [Opdivo] — DRUG
  Nivolumab will be given intravenously on specified days for four consecutive 21-day dosing cycles for a total period of approximately 84 days

Study Details

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.

Key Dates

Start date

Jan 2, 2019

Status verified

Aug 2024

Primary completion

Dec 11, 2019

Completion

Dec 11, 2019

Study Design

Enrollment

13 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: TAR-200 and Nivolumab Combination
  Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 is placed into the bladder through an Inserter and gradually releases gemcitabine during the 21-day indwelling period before being removed. In combination, subjects are dosed intravenously with a Nivolumab Injection \[Opdivo\] within 3 days of TAR-200 placement. Subjects will receive four consecutive 21-day dosing cycles of the combination of TAR-200 and Nivolumab prior to radical cystectomy.

Primary Outcome Measure

Number of participants with incidence of treatment emergent adverse events (TEAEs) over 4 consecutive 21-day dosing cycles of TAR-200 in combination with Nivolumab as assessed by CTCAE V4.0. [ Time Frame: Study Day 0 to Study Day 180 ]

Locations (6)

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