deltatrials
Terminated PHASE1 INTERVENTIONAL 1-arm NCT03518320

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

A Multicenter Study of TAR-200 in Combination With Nivolumab (OPDIVO) in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

Sponsor: Bristol-Myers Squibb

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
Interventions Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 Nivolumab Injection [Opdivo]
Updated 9 times since 2018 Last updated: Aug 23, 2024 Started: Jan 2, 2019 Primary completion: Dec 11, 2019 Completion: Dec 11, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business objectives have changed

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A PHASE1 clinical study on Bladder Cancer TNM Staging Distant Metastasis (M) M0 and Bladder Cancer TNM Staging Primary Tumor (T) T2, this trial is terminated or withdrawn. The trial is conducted by Bristol-Myers Squibb and has accumulated 9 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotNot Yet Recruiting~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshotRecruiting~Dec 2018 – ~May 2019 · 5 months · monthly snapshotRecruiting~May 2019 – ~Apr 2020 · 11 months · monthly snapshotRecruiting~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshotActive Not Recruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Aug 2020 — Jan 2021 [monthly]

    Terminated PHASE1

    Status: Active Not Recruiting → Terminated

  5. Apr 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

▶ Show 4 earlier versions

  1. May 2019 — Apr 2020 [monthly]

    Recruiting PHASE1

  2. Dec 2018 — May 2019 [monthly]

    Recruiting PHASE1

  3. Sep 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  4. Jun 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb
  • Taris Biomedical LLC
Data source: Taris Biomedical LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations