Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies
3 other identifiers
interventional
404
13 countries
106
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2019
Longer than P75 for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
April 23, 2026
April 1, 2026
6.5 years
November 14, 2019
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
up to 7 years
Study Arms (18)
A - Tislelizumab Monotherapy
EXPERIMENTALB - Pamiparib Monotherapy
EXPERIMENTALC - Sitravatinib Monotherapy
EXPERIMENTALD - BGB-15025 Monotherapy
EXPERIMENTALE - Zanidatamab Monotherapy
EXPERIMENTALF - Pamiparib and Temozolomide Combination Therapy
EXPERIMENTALG - Tislelizumab and Pamiparib Combination Therapy
EXPERIMENTALH - Tislelizumab and Sitravatinib Combination Therapy
EXPERIMENTALI - Tislelizumab and Ociperlimab Combination Therapy
EXPERIMENTALJ - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy
EXPERIMENTALK - Tislelizumab and Fruquintinib Combination Therapy
EXPERIMENTALL - Tislelizumab and BGB-A445 Combination Therapy
EXPERIMENTALM - Tislelizumab and Surzebiclimab Combination Therapy
EXPERIMENTALN - Tislelizumab and BGB-15025 Combination Therapy
EXPERIMENTALO - Tislelizumab and Lenvatinib Combination Therapy
EXPERIMENTALP - Tislelizumab and Zanidatamab Combination Therapy
EXPERIMENTALQ - Tislelizumab and LBL-007 Combination Therapy
EXPERIMENTALR - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy
EXPERIMENTALInterventions
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered orally.
Administered intravenously.
Administered intravenously.
Administered intravenously.
Administered orally.
Administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (106)
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140-2840, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203, United States
Baylor Research Institute
Dallas, Texas, 75246-2079, United States
Prince of Wales Hospital
Randwick, New South Wales, NSW 2031, Australia
Northern Cancer Institute
St Leonards, New South Wales, NSW 2065, Australia
Calvary Mater Newcastle
Waratah, New South Wales, NSW 2298, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, QLD 4101, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, SA 5011, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000, Australia
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, 510000, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The Fifth Affiliated Hospital Sun Yat Sen University
Zhuhai, Guangdong, 519000, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Second Affiliated Hospital of Zunyi Medical University
Zuiyi, Guizhou, 550002, China
Hainan Cancer Hospital
Haikou, Hainan, 570312, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Zhongnan Hospital of Wuhan University Wuhan
Wuhan, Hubei, 430071, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Weifang Peoples Hospital
Weifang, Shandong, 261000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610101, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Provincial Wenzhou Hospital of Zhejiang
Wenzhou, Zhejiang, 325000, China
Hopital Beaujon
Clichy, 92110, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Icm Val Daurelle
Montpellier, 34090, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000, France
Hopital Larchet 2 Chu Nice
Nice, 06200, France
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Aou Pisana, Stabilimento Di Santa Chiara
Pisa, 56126, Italy
Azienda Ospedaliera S Maria Di Terni
Terni, 05100, Italy
Akita University Hospital
Akitashi, Akita, 010-8543, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Nho Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Izumi City General Hospital
Izumishi, Osaka, 594-0073, Japan
The University of Osaka Hospital
Suitashi, Osaka, 565-0871, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, 104-0045, Japan
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Auckland City Hospital
Auckland, 1023, New Zealand
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
Warsaw, 02-781, Poland
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, 21565, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, 58128, South Korea
Smg Snu Boramae Medical Center
DongjakGu, Seoul Teugbyeolsi, 07061, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, 08308, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Chiayi Chang Gung Memorial Hospital
Chiayi City, 61363, Taiwan
Linkou Chang Gung Memorial Hospital
Guishan Dist, 33305, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Niaosong Dist, 83301, Taiwan
National Cheng Kung University Hospital
North Dist, 704, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Chi Mei Medical Center
Yongkang Dist, 710, Taiwan
King Chulalongkorn Memorial Hospital (Chulalongkorn University)
Pathum Wan, 10330, Thailand
Acibadem Adana Hospital
Kuruköprü, 01060, Turkey (Türkiye)
Bakirkoy Sadi Konuk Eah
stanbulBakrkoy, 34147, Turkey (Türkiye)
Namik Kemal University
Tekirdağ, 59100, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 15, 2019
Study Start
December 19, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.