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Brief Title: Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Patients With Urothelial Carcinoma

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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

INTRODUCTION

  • Org Study ID: BGB-A317-310
  • Secondary ID: N/A
  • NCT ID: NCT03967977
  • Sponsor: BeiGene

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    May 29, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall survival (OS) in the Intent to Treat (ITT) set

Primary Outcome 1 - Timeframe: From first randomization up to 3.5 years

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

Key Inclusion Criteria:
1. Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)

- 2. Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC)

- 3. Must be eligible to receive cisplatin or carboplatin in the investigator's judgment

- 4. Have had no prior systemic chemotherapy for locally advanced or metastatic UC

- 5. Must be able to provide fresh or archival tumor tissues with an associated pathological report.

- 6. Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.

- 7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

- 8. Adequate organ function before randomization:
Key Exclusion Criteria:
1. 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.

- 2. Any approved anticancer therapy within 28 days before randomization.

- 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis

- 4. Participants with uncontrolled hypercalcemia

- 5. Participants with active autoimmune diseases or history of autoimmune diseases that may relapse

- 6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases

- 7. A known history of HIV infection.

- 8. Prior allogeneic stem cell transplantation or organ transplantation.

- 9. 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Dingwei Ye, MD

Role: Principal Investigator

Affiliation: Fudan University

Overall Contact

Name: BeiGene

Phone: +1-877-828-5568

Email: [email protected]

LOCATION

Facility Status Contact

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