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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

December 31, 2021

Study Completion Date

August 31, 2023

Conditions
Urinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsAntineoplastic AgentsUrinary Bladder DiseasesTislelizumab 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).

Trial Locations (1)

200127

RECRUITING

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BeiGene

INDUSTRY

collaborator

Huidu Shanghai Medical Sciences Ltd

UNKNOWN

lead

RenJi Hospital

OTHER

NCT04922047 - Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01) | Biotech Hunter | Biotech Hunter