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
NCT ID: NCT03967977
Sponsor: BeiGene

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 Outcome 1 - Measure: Overall survival (OS) in the ITT set

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

Urothelial Carcinoma

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

Name: Dingwei Ye, MD

Role: Principal Investigator

Affiliation: Fudan University

Name: Dingwei Ye, MD

Phone: +1-877-828-5568

Email: clinicaltrials@beigene.com

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

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

INTRODUCTION

BRIEF SUMMARY

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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