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

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: CTR20190543
  • NTC 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 patients 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 ITT set

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

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY


Inclusion Criteria:

1. Male or female aged 18 to 75 years on the day of signing the ICF

2. Histologically confirmed, inoperable, locally advanced, or metastatic 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. ECOG Performance Status 0 or 1.

8. Adequate organ function before randomization:

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. patients with uncontrolled hypercalcemia

5. patents 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.

Gender: All

Minimum Age: 75 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Dingwei Ye, MD

Role: Principal Investigator

Affiliation: Fudan University

Overall Contact

Name: Dingwei Ye, MD

Phone: +1-877-828-5568

Email: clinicaltrials@beigene.com

LOCATION

Facility Status Contact
Facility: Beijing Cancer Hospital
Beijing, Beijing 100142
China
Status: Recruiting Contact: N/A
Facility: Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing
China
Status: Recruiting Contact: N/A
Facility: Peking University First Hospital
Beijing, Beijing
China
Status: Recruiting Contact: N/A
Facility: Chongqing Cancer Hospital
Chongqing, Chongqing
China
Status: Recruiting Contact: N/A
Facility: Southwest Hospital
Chongqing, Chongqing
China
Status: Recruiting Contact: N/A
Facility: The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
China
Status: Recruiting Contact: N/A
Facility: Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang
China
Status: Recruiting Contact: N/A
Facility: Hubei Cancer Hospital
Wuhan, Hubei
China
Status: Recruiting Contact: N/A
Facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
China
Status: Recruiting Contact: N/A
Facility: Xiangya Hospital of Central South University
Changsha, Hunan
China
Status: Recruiting Contact: N/A
Facility: Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
China
Status: Recruiting Contact: N/A
Facility: The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
China
Status: Recruiting Contact: N/A
Facility: The First Hospital of Jilin University
Changchun, Jilin
China
Status: Recruiting Contact: N/A
Facility: Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
China
Status: Recruiting Contact: N/A
Facility: Fudan University Shanghai Cancer Center
Shanghai, Shanghai
China
Status: Recruiting Contact: N/A
Facility: Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai
China
Status: Recruiting Contact: N/A
Facility: The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi
China
Status: Recruiting Contact: N/A
Facility: West China Hospital,Sichuan University / West China Hospital of Medicine, Sichuan University
Chengdu, Sichuan
China
Status: Recruiting Contact: N/A
Facility: The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin
China
Status: Recruiting Contact: N/A
Facility: Zhejiang Cancer Hospital
Hangzhou, Zhejiang
China
Status: Recruiting Contact: N/A
Facility: Ningbo First Hospital
Ningbo, Zhejiang
China
Status: Recruiting Contact: N/A
Facility: The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
China
Status: Recruiting Contact: N/A