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Advanced MalignanciesPhase 3NCT04164199

Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

A Phase 3 study testing Tislelizumab, Pamiparib and Temozolomide in people with Advanced Malignancies, run by BeOne Medicines at 106 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene or BeOne investigational drugs in participants with advanced malignancies who participated in a prior BeiGene- or BeOne-sponsored clinical study (parent study). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignancies
What is being tested?
Tislelizumab, Pamiparib and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
106 sitesin 13 countries
Study dates
19 Dec 2019to 23 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently participating in a BeiGene- or BeOne-sponsored eligible parent study
  • Fulfills treatment criteria specified in the parent study protocol
  • In the opinion of the investigator, the participant will continue to benefit from and tolerate any of the parent study treatments.
  • The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study:
  • "Treatment interruption" is an unplanned pause in study treatment (eg, due to adverse event). Restarting study treatment beyond the interruption period allowed by the parent study will be determined by the investigator and the sponsor.

Who cannot join

  • Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
  • Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study
  • Have a medical condition or organ system dysfunction that in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of investigational drugs, or put the study outcomes at undue risk
  • Underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the LTE study
  • Pregnant or lactating women
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

106 sites in 13 countries.

106 sites in 13 countries

China50 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • The Affiliated Hospital of Military Medical Sciences

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610101

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

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

    Guangzhou, Guangdong, 510000

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

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

    Guangzhou, Guangdong, 510245

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

  • The First Provincial Wenzhou Hospital of Zhejiang

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430030

  • Zhongnan Hospital of Wuhan University Wuhan

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • The Fifth Affiliated Hospital Sun Yat Sen University

    Zhuhai, Guangdong, 519000

  • The Second Affiliated Hospital of Zunyi Medical University

    Zuiyi, Guizhou, 550002

Other trials in China

South Korea14 sites

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do, 13496

  • Smg Snu Boramae Medical Center

    DongjakGu, Seoul Teugbyeolsi, 07061

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

  • Korea University Guro Hospital

    GuroGu, Seoul Teugbyeolsi, 08308

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do, 58128

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    NamdongGu, Incheon Gwang'yeogsi, 21565

  • The Catholic University of Korea, St Vincents Hospital

    PaldalGu SuwonSi, Gyeonggi-do, 16247

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Australia7 sites

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

  • Prince of Wales Hospital

    Randwick, New South Wales, NSW 2031

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, QLD 4101

  • Northern Cancer Institute

    St Leonards, New South Wales, NSW 2065

  • Calvary Mater Newcastle

    Waratah, New South Wales, NSW 2298

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, SA 5011

Other trials in Australia

Japan7 sites

  • Akita University Hospital

    Akitashi, Akita, 010-8543

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    ChuoKu, Tokyo, 104-0045

  • Nho Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Izumi City General Hospital

    Izumishi, Osaka, 594-0073

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • The University of Osaka Hospital

    Suitashi, Osaka, 565-0871

Other trials in Japan

Taiwan7 sites

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, 61363

  • Linkou Chang Gung Memorial Hospital

    Guishan Dist, 33305

  • Kaohsiung Chang Gung Memorial Hospital

    Niaosong Dist, 83301

  • National Cheng Kung University Hospital

    North Dist, 704

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407

  • Chi Mei Medical Center

    Yongkang Dist, 710

Other trials in Taiwan

France5 sites

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Prive Jean Mermoz

    Lyon, 69008

  • Icm Val Daurelle

    Montpellier, 34090

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44000

  • Hopital Larchet 2 Chu Nice

    Nice, 06200

Other trials in France

United States4 sites

  • Baylor Research Institute

    Dallas, Texas, 75246-2079

  • Mount Sinai Medical Center Braman Comprehensive Cancer Center

    Miami, Florida, 33140

  • Tennessee Oncology, Pllc Nashville

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

Other trials in United States

Italy3 sites

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

  • Aou Pisana, Stabilimento Di Santa Chiara

    Pisa, 56126

  • Azienda Ospedaliera S Maria Di Terni

    Terni, 05100

Other trials in Italy

Turkey (Türkiye)3 sites

  • Acibadem Adana Hospital

    Kuruköprü, 01060

  • Bakirkoy Sadi Konuk Eah

    stanbulBakrkoy, 34147

  • Namik Kemal University

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

Malaysia2 sites

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, 93586

Other trials in Malaysia

Poland2 sites

  • Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

    Gdynia, 81-519

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    Warsaw, 02-781

Other trials in Poland

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

Thailand1 site

  • King Chulalongkorn Memorial Hospital (Chulalongkorn University)

    Pathum Wan, 10330

Other trials in Thailand

About this study

Official title: An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene or BeOne investigational drugs in participants with advanced malignancies who participated in a prior BeiGene- or BeOne-sponsored clinical study (parent study).

Read the detailed description

For the purposes of this study, "study treatment" will refer to all investigational agents. A parent study is defined as the original BeiGene- or BeOne-sponsored clinical trial in which the participant was initially enrolled and received BeiGene or BeOne investigational drugs (with or without other treatments).

Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Being tested
Tislelizumab, Pamiparib, Temozolomide, Sitravatinib, Ociperlimab

What participants receive

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

  • TislelizumabDrug

    Also called BGB-A317

    Administered intravenously.

  • PamiparibDrug

    Also called BGB-290

    Administered orally.

  • TemozolomideDrug

    Administered orally.

  • SitravatinibDrug

    Administered orally.

  • OciperlimabDrug

    Also called BGB-A1217

    Administered intravenously.

  • BAT1706Drug

    Administered intravenously.

  • FruquintinibDrug

    Administered orally.

  • BGB-15025Drug

    Administered orally.

  • ZanidatamabDrug

    Also called ZW25

    Administered intravenously.

  • BGB-A445Drug

    Also called Gimistotug

    Administered intravenously.

  • SurzebiclimabDrug

    Also called BGB-A425

    Administered intravenously.

  • LenvatinibDrug

    Administered orally.

  • LBL-007Drug

    Also called Alcestobart

    Administered intravenously.

Study groups in NCT04164199
Study groupRoleWhat they receive
A - Tislelizumab MonotherapyExperimentalNot described
Receives: Drug: Tislelizumab
B - Pamiparib MonotherapyExperimentalNot described
Receives: Drug: Pamiparib
C - Sitravatinib MonotherapyExperimentalNot described
Receives: Drug: Sitravatinib
D - BGB-15025 MonotherapyExperimentalNot described
Receives: Drug: BGB-15025
E - Zanidatamab MonotherapyExperimentalNot described
Receives: Drug: Zanidatamab
F - Pamiparib and Temozolomide Combination TherapyExperimentalNot described
Receives: Drug: Pamiparib; Drug: Temozolomide
G - Tislelizumab and Pamiparib Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Pamiparib
H - Tislelizumab and Sitravatinib Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Sitravatinib
I - Tislelizumab and Ociperlimab Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Ociperlimab
J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 MonotherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: BAT1706
K - Tislelizumab and Fruquintinib Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Fruquintinib
L - Tislelizumab and BGB-A445 Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: BGB-A445
M - Tislelizumab and Surzebiclimab Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Surzebiclimab
N - Tislelizumab and BGB-15025 Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: BGB-15025
O - Tislelizumab and Lenvatinib Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Lenvatinib
P - Tislelizumab and Zanidatamab Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Zanidatamab
Q - Tislelizumab and LBL-007 Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: LBL-007
R - Tislelizumab and Surzebiclimab and LBL-007 Combination TherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Surzebiclimab; Drug: LBL-007

What is being measured

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

  1. Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher

    Safety as assessed by the number of participants with immune-mediated adverse events (imAEs), ≥ Grade 3 adverse events, and serious adverse events.

    Measured: up to 7 years

Timeline

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

  1. First posted15 Nov 2019
  2. Study start19 Dec 2019
  3. Primary completion23 May 2026
  4. Study completion23 May 2026

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04164199
Sponsor's protocol ID
BGB-A317-290-LTE1
Other IDs
2019-002554-23, 2023-508883-31-00, 2023, 2019
Status last verified
Jun 2026
First submitted
14 Nov 2019
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne 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. BeOne 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 BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Pamiparib and Temozolomide in people with Advanced Malignancies, run by BeOne Medicines at 106 sites in 13 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 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 106 sites in China, South Korea, Australia, Japan, Taiwan and 8 more countries. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with Immune-Mediated Adverse Events, Serious Adverse Events, and Adverse Events Grade 3 or Higher (time frame: up to 7 years). 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 NCT04164199.

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 3 Jun 2026.

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