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Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)

NCT04922047 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-06-11

No results posted yet for this study

Summary

This study is a single-arm, open-label, single-center study to assess the safety of tislelizumab with BCG, and to obtain the preliminary efficacy results in subjects who have been diagnosed with high-risk NMIBC without prior BCG treatment.

Conditions

  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Antineoplastic Agents
  • Urinary Bladder Diseases
  • Tislelizumab Antineoplastic Agents, Immunological

Interventions

DRUG

tislelizumab and BCG

Tislelizumab 200 mg administered by intravenous infusion every 3 weeks in first year and continue to second year based on physician choose. BCG 120 mg induction therapy administered via intravesical instillation (once weekly for 6 weeks). BCG induction therapy is followed by maintenance therapy (once weekly for 3 weeks at months 3, 6, 12, 18, 24m).

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Huidu Shanghai Medical Sciences Ltd

    collaborator UNKNOWN

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Wei XUE, MD, PHD · Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-12-31
Completion
2023-08-31

Countries

  • China

Study Locations

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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 NCT04922047 on ClinicalTrials.gov