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Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

NCT03967977 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-04-23

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Conditions

Interventions

DRUG

Tislelizumab

200 mg administered Intravenously (IV) as specified in the treatment arm

DRUG

Placebo

Tislelizumab placebo to match

DRUG

Cisplatin

70 mg/m2 administered IV as specified in the treatment arm

DRUG

Gemcitabine Hydrochloride

1000 mg/m2 administered IV as specified in the treatment arm

DRUG

Carboplatin

Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Dingwei Ye, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2027-06-30
Completion
2027-10-21

Countries

  • China
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03967977 on ClinicalTrials.gov