Combining Tislelizumab with Chemotherapy for 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

This study is testing if adding a new drug called tislelizumab to standard chemotherapy can help people with advanced bladder cancer feel better and live longer compared to just chemotherapy alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: BeiGene (Industry-sponsored)
• Drugs / interventions: chemotherapy, tislelizumab
• Locations: 46 sites (Hefei, Anhui and 45 other locations)
• Trial ID: NCT03967977 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the effectiveness and safety of tislelizumab in combination with chemotherapy agents (cisplatin or carboplatin plus gemcitabine) compared to a placebo with the same chemotherapy regimen. The study involves approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not previously received systemic therapy. It is designed as a multicenter, randomized, double-blind, placebo-controlled trial to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed, inoperable, locally advanced, or metastatic urothelial carcinoma who have not received prior systemic chemotherapy.

Not a fit: Patients who have previously received therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or other checkpoint pathways may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced urothelial carcinoma, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in urothelial carcinoma, suggesting potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 45 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Active_not_recruiting)
• Peking University Third Hospital — Beijing, Beijing, China (Active_not_recruiting)
• Peking University First Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
• Fifth Medical Center of Pla General Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Completed)
• Chinese Pla General Hospital — Beijing, Beijing, China (Completed)
• Chongqing Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
• Southwest Hospital — Chongqing, Chongqing, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Active_not_recruiting)
• Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Active_not_recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Active_not_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Completed)
• Jiangsu Province Cancer Hospital — Nanjing, Jiangsu, China (Active_not_recruiting)
• Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University Branch Donghu — Nanchang, Jiangxi, China (Active_not_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (Active_not_recruiting)
• The Second Affiliated Hospital of Xian Jiaotong University — Xian, Shaanxi, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
• Rui Jin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Active_not_recruiting)
• Affiliated Zhongshan Hospital of Fudan University — Shanghai, Shanghai, China (Active_not_recruiting)
• Huadong Hospital Affiliated to Fudan University — Shanghai, Shanghai, China (Completed)
• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai, China (Completed)
• Shanghai Changhai Hospital — Shanghai, Shanghai, China (Completed)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, Sichuan, China (Active_not_recruiting)
• The Second Affiliated Hospital of Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)
• Affiliated Cancer Hospital of Xinjiang Medical University — Urumqi, Xinjiang, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Active_not_recruiting)
• Zhejiang Provincial Peoples Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Completed)
• Ningbo First Hospital — Ningbo, Zhejiang, China (Completed)
• The First Provincial Wenzhou Hospital of Zhejiang — Wenzhou, Zhejiang, China (Recruiting)
• Keelung Chang Gung Memorial Hospital and Loves Lake Branch — Anle Dist, Taiwan (Completed)
• Taipei Veterans General Hospital — Beitou Dist, Taiwan (Completed)
• Linkou Chang Gung Memorial Hospital — Guishan Dist, Taiwan (Completed)
• National Cheng Kung University Hospital — North Dist, Taiwan (Completed)
• National Taiwan University Hospital — Zhongzheng Dist, Taiwan (Completed)

Study contacts

• Principal investigator: Dingwei Ye, MD — Fudan University
• Study coordinator: BeiGene

Conditions Urothelial Carcinoma