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Urothelial CarcinomaPhase 3NCT03967977

Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

A Phase 3 study testing Tislelizumab, Cisplatin and Gemcitabine Hydrochloride in people with Urothelial Carcinoma, run by BeiGene at 46 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Tislelizumab, Cisplatin and Gemcitabine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
46 sitesin 2 countries
Study dates
29 May 2019to 21 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)
  • Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC)
  • Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
  • Have had no prior systemic chemotherapy for locally advanced or metastatic UC
  • Must be able to provide fresh or archival tumor tissues with an associated pathological report.
  • Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Adequate organ function before randomization:

Who cannot join

  • 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.
  • Any approved anticancer therapy within 28 days before randomization.
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Participants with uncontrolled hypercalcemia
  • Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
  • History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
Show all 10Show fewer
  • A known history of HIV infection.
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • 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.

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

China41 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Fifth Medical Center of Pla General Hospital

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

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

    Guangzhou, Guangdong, 510245

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Cancer Hospital

    Nanjing, Jiangsu, 210008

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

    Nanjing, Jiangsu, 210008

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362001

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The Second Affiliated Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • The First Provincial Wenzhou Hospital of Zhejiang

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

Taiwan5 sites

  • Keelung Chang Gung Memorial Hospital and Loves Lake Branch

    Anle Dist, 204

  • Taipei Veterans General Hospital

    Beitou Dist, 11217

  • Linkou Chang Gung Memorial Hospital

    Guishan Dist, 33305

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Zhongzheng Dist, 100225

Other trials in Taiwan

About this study

Official title: 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 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.

Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    200 mg administered Intravenously (IV) as specified in the treatment arm

  • PlaceboDrug

    Tislelizumab placebo to match

  • CisplatinDrug

    70 mg/m2 administered IV as specified in the treatment arm

  • Gemcitabine HydrochlorideDrug

    1000 mg/m2 administered IV as specified in the treatment arm

  • CarboplatinDrug

    Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm

Study groups in NCT03967977
Study groupRoleWhat they receive
Tislelizumab in combination with chemotherapyActive comparatorTislelizumab: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles
Receives: Drug: Tislelizumab; Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Drug: Carboplatin
Placebo in combination with chemotherapyPlacebo comparatorPlacebo: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles
Receives: Drug: Placebo; Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS) in the Intent to Treat (ITT) set

    Measured: From first randomization up to 3.5 years, approximately

Secondary outcomes (7)

  1. Overall response rate (ORR) per RECIST v1.1 in ITT

    the proportion of participants who had Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST v1.1 in the ITT Analysis Set

    Measured: From first randomization up to 3.5 years, approximately

  2. Duration of response (DOR)

    the time from the first occurrence of a documented objective response to documented Progressive Disease (PD), or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

    Measured: From first randomization up to 3.5 years, approximately

  3. Progression-free survival (PFS)

    the time from randomization to the first objectively documented PD, or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

    Measured: From first randomization up to 3.5 years, approximately

  4. Overall survival rate at 1 and 2 years for each treatment arm

    the proportion of OS participants at 1 year and 2 years from randomization in the ITT Analysis Set

    Measured: From first randomization up to 3.5 years, approximately

  5. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)

    1. to assess overall health status/Quality of Life with 2 questions which are with range from minimum score 1 as worse outcome and maximum score 7 as higher values represent a better 2) to assess quality of life with 28 questions about Physical functioning, emotional functioning, social functioning etc. which are with range from minimum scores 1 representing as better to maximum scores 4 as worse outcome.

    Measured: From first randomization up to 3.5 years, approximately

  6. Incidence and severity of treatment-emergent adverse events (AEs)

    Incidence and severity of treatment-emergent adverse events (AEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)v5.0

    Measured: From first randomization up to 3.5years, approximately

  7. Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L)

    to assess health status with 1) 5 questions about Mobility, Self-Care, Usual activities, Pain/Discomfort, Anxiety/Depression which are with 5 options. 2) one question about health status at the day of completing the questionnaire with range from minimum score 0 as worse outcome to maximum scores 100 as higher values represent as better.

    Measured: From first randomization up to 3.5 years, approximately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start29 May 2019
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion21 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03967977
Sponsor's protocol ID
BGB-A317-310
Other IDs
CTR20190543
Status last verified
Apr 2026
First submitted
23 May 2019
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Publications

  • Huang H, Dai Z, Jiang Z, Li X, Ma L, Ji Z, Fan X. Anti-PD-1 immunotherapy for the treatment of metastatic urothelial carcinoma in a kidney transplant recipient: a case report. BMC Nephrol. 2024 Oct 31;25(1):390. doi: 10.1186/s12882-024-03825-2.

    PubMed 39482589

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Cisplatin and Gemcitabine Hydrochloride in people with Urothelial Carcinoma, run by BeiGene at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) in the Intent to Treat (ITT) set (time frame: From first randomization up to 3.5 years, approximately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03967977, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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