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New drug combo shows promise in advanced bladder cancer trial

NCT ID NCT03967977

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the immunotherapy drug tislelizumab to standard chemotherapy helps people with advanced bladder cancer live longer. About 420 adults who have not had prior treatment for their advanced cancer will receive either tislelizumab plus chemo or a placebo plus chemo. The main goal is to see if the combination improves overall survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

420 people

The number who actually took part.

Started

May 2019

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urothelial carcinoma

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Fifth Medical Center of Pla General Hospital

    Beijing, Beijing Municipality, 100071, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Jiangsu Province Cancer Hospital

    Nanjing, Jiangsu, 210008, China

  • Keelung Chang Gung Memorial Hospital and Loves Lake Branch

    Anle Dist, 204, Taiwan

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Linkou Chang Gung Memorial Hospital

    Guishan Dist, 33305, Taiwan

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Zhongzheng Dist, 100225, Taiwan

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071, China

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038, China

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    Guangzhou, Guangdong, 510245, China

  • Taipei Veterans General Hospital

    Beitou Dist, 11217, Taiwan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First Provincial Wenzhou Hospital of Zhejiang

    Wenzhou, Zhejiang, 325000, China

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362001, China

  • The Second Affiliated Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000, China

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710004, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.