NCT03518320

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

Terminated Phase 1 Last updated 27 August 2024

What this trial tests

Phase 1 trial testing Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 in Bladder Cancer TNM Staging Primary Tumor (T) T2 in 13 participants. Terminated before completion.

Timeline

2 January 2019

Primary endpoint
11 December 2019

11 December 2019

Quick facts

Lead sponsor	Taris Biomedical LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	2 January 2019
Primary completion	11 December 2019
Estimated completion	11 December 2019
Sites	6 locations across United States

Drugs / interventions tested

• Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 — full drug profile →
• Nivolumab Injection [Opdivo] — full drug profile →

Conditions studied

• Bladder Cancer TNM Staging Primary Tumor (T) T2 — all drugs for Bladder Cancer TNM Staging Primary Tumor (T) T2 →
• Bladder Cancer TNM Staging Primary Tumor (T) T2A — all drugs for Bladder Cancer TNM Staging Primary Tumor (T) T2A →
• Bladder Cancer TNM Staging Primary Tumor (T) T2B — all drugs for Bladder Cancer TNM Staging Primary Tumor (T) T2B →
• Bladder Cancer TNM Staging Primary Tumor (T) T3 — all drugs for Bladder Cancer TNM Staging Primary Tumor (T) T3 →

Sponsor

Taris Biomedical LLC — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer TNM Staging Primary Tumor (T) T2 or Bladder Cancer TNM Staging Primary Tumor (T) T2A. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune Checkpoint Inhibitors as a Neoadjuvant/Adjuvant Treatment of Muscle-Invasive Bladder Cancer: A Systematic Review.
   Barone B, Calogero A, Scafuri L, Ferro M, et al · · 2022 · cited 43× · PMID 35626149 · DOI 10.3390/cancers14102545
2. Perioperative Systemic Treatment for Muscle-Invasive Bladder Cancer: Current Evidence and Future Perspectives.
   Kim IH, Lee HJ. · · 2021 · cited 18× · PMID 34281253 · DOI 10.3390/ijms22137201
3. The immunotherapy revolution in genitourinary malignancies.
   U Gandhy S, Madan RA, Aragon-Ching JB. · · 2020 · cited 8× · PMID 32594815 · DOI 10.2217/imt-2020-0054
4. Perioperative immunotherapy for muscle-invasive bladder cancer.
   Kim IH, Lee HJ. · · 2020 · cited 5× · PMID 33457270 · DOI 10.21037/tau.2019.11.31
5. The promise of immunotherapy in genitourinary malignancies.
   Zhang T, Armstrong AJ, George DJ, Huang J. · · 2018 · cited 5× · PMID 30687563 · DOI 10.1093/pcmedi/pby018