Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03967977

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)
  • Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC)
  • Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
  • Have had no prior systemic chemotherapy for locally advanced or metastatic UC
  • Must be able to provide fresh or archival tumor tissues with an associated pathological report.
  • Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Adequate organ function before randomization:

Key Exclusion Criteria:

  • Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Any approved anticancer therapy within 28 days before randomization.
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Participants with uncontrolled hypercalcemia
  • Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
  • History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
  • A known history of HIV infection.
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • History of severe hypersensitivity reactions to other monoclonal antibodies. 10.History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Tislelizumab

Drug

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

Other names: BGB-A317

Placebo

Drug

Tislelizumab placebo to match

Cisplatin

Drug

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

gemcitabine hydrochloride

Drug

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

carboplatin

Drug

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

Primary outcomes

  1. Overall survival (OS) in the Intent to Treat (ITT) set

    Time frame: From first randomization up to 3.5 years, approximately

Secondary outcomes

  1. Overall response rate (ORR) per RECIST v1.1 in ITT

    Time frame: From first randomization up to 3.5 years, approximately

    the proportion of participants who had Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST v1.1 in the ITT Analysis Set

  2. Duration of response (DOR)

    Time frame: From first randomization up to 3.5 years, approximately

    the time from the first occurrence of a documented objective response to documented Progressive Disease (PD), or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

  3. Progression-free survival (PFS)

    Time frame: From first randomization up to 3.5 years, approximately

    the time from randomization to the first objectively documented PD, or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

  4. Overall survival rate at 1 and 2 years for each treatment arm

    Time frame: From first randomization up to 3.5 years, approximately

    the proportion of OS participants at 1 year and 2 years from randomization in the ITT Analysis Set

  5. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)

    Time frame: From first randomization up to 3.5 years, approximately

    • to assess overall health status/Quality of Life with 2 questions which are with range from minimum score 1 as worse outcome and maximum score 7 as higher values represent a better 2) to assess quality of life with 28 questions about Physical functioning, emotional functioning, social functioning etc. which are with range from minimum scores 1 representing as better to maximum scores 4 as worse outcome.
  6. Incidence and severity of treatment-emergent adverse events (AEs)

    Time frame: From first randomization up to 3.5years, approximately

    Incidence and severity of treatment-emergent adverse events (AEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)v5.0

  7. Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L)

    Time frame: From first randomization up to 3.5 years, approximately

    to assess health status with 1) 5 questions about Mobility, Self-Care, Usual activities, Pain/Discomfort, Anxiety/Depression which are with 5 options. 2) one question about health status at the day of completing the questionnaire with range from minimum score 0 as worse outcome to maximum scores 100 as higher values represent as better.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin +Gemcitabine + Tislelizumab Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-line Treatment for Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 30, 2019
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.