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Clinical Trial NCT04164199 for Advanced Malignancies is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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BeOne MedicinesStudy of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies Phase 3 404 Open-Label
Clinical Trial NCT04164199 is designed to study Treatment for Advanced Malignancies. It is a Phase 3 interventional study that is active, not recruiting, having started on 19 December 2019, with plans to enroll 404 participants. Led by BeOne Medicines, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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).
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 old...
Show MoreOfficial Title
An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies
Conditions
Advanced MalignanciesOther Study IDs
- BGB-A317-290-LTE1
- 2019-002554-23 (EudraCT Number)
- 2023-508883-31-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2019-12-19
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
404
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalA - Tislelizumab Monotherapy | Tislelizumab Administered intravenously. |
ExperimentalB - Pamiparib Monotherapy | Pamiparib Administered orally. |
ExperimentalC - Sitravatinib Monotherapy | Sitravatinib Administered orally. |
ExperimentalD - BGB-15025 Monotherapy | BGB-15025 Administered orally. |
ExperimentalE - Zanidatamab Monotherapy | Zanidatamab Administered intravenously. |
ExperimentalF - Pamiparib and Temozolomide Combination Therapy | Pamiparib Administered orally. Temozolomide Administered orally. |
ExperimentalG - Tislelizumab and Pamiparib Combination Therapy | Tislelizumab Administered intravenously. Pamiparib Administered orally. |
ExperimentalH - Tislelizumab and Sitravatinib Combination Therapy | Tislelizumab Administered intravenously. Sitravatinib Administered orally. |
ExperimentalI - Tislelizumab and Ociperlimab Combination Therapy | Tislelizumab Administered intravenously. Ociperlimab Administered intravenously. |
ExperimentalJ - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy | Tislelizumab Administered intravenously. BAT1706 Administered intravenously. |
ExperimentalK - Tislelizumab and Fruquintinib Combination Therapy | Tislelizumab Administered intravenously. Fruquintinib Administered orally. |
ExperimentalL - Tislelizumab and BGB-A445 Combination Therapy | Tislelizumab Administered intravenously. BGB-A445 Administered intravenously. |
ExperimentalM - Tislelizumab and Surzebiclimab Combination Therapy | Tislelizumab Administered intravenously. Surzebiclimab Administered intravenously. |
ExperimentalN - Tislelizumab and BGB-15025 Combination Therapy | Tislelizumab Administered intravenously. BGB-15025 Administered orally. |
ExperimentalO - Tislelizumab and Lenvatinib Combination Therapy | Tislelizumab Administered intravenously. Lenvatinib Administered orally. |
ExperimentalP - Tislelizumab and Zanidatamab Combination Therapy | Tislelizumab Administered intravenously. Zanidatamab Administered intravenously. |
ExperimentalQ - Tislelizumab and LBL-007 Combination Therapy | Tislelizumab Administered intravenously. LBL-007 Administered intravenously. |
ExperimentalR - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy | Tislelizumab Administered intravenously. Surzebiclimab Administered intravenously. LBL-007 Administered intravenously. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
- 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.
BeOne Medicines130 active studies to exploreNo contact data.
106 Study Locations in 13 Countries
New South Wales
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
Queensland
Icon Cancer Centre South Brisbane, South Brisbane, Queensland, QLD 4101, Australia
South Australia
The Queen Elizabeth Hospital, Woodville South, South Australia, SA 5011, Australia
Victoria
Monash Health, Clayton, Victoria, VIC 3168, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, VIC 3000, Australia
Auckland City Hospital, Auckland, 1023, New Zealand
Florida
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, 33140-2840, United States
New York
Memorial Sloan Kettering Cancer Center Mskcc, New York, New York, 10065-6800, United States
Tennessee
Tennessee Oncology, Pllc Nashville, Nashville, Tennessee, 37203, United States
Texas
Baylor Research Institute, Dallas, Texas, 75246-2079, United States
Anhui
The Second Hospital of Anhui Medical University, Hefei, Anhui, 230601, China
Beijing Municipality
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 Municipality
Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, 400030, China
Fujian
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
Guangdong
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
Guangxi
The Peoples Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530021, China
Guizhou
The Second Affiliated Hospital of Zunyi Medical University, Zuiyi, Guizhou, 550002, China
Hainan
Hainan Cancer Hospital, Haikou, Hainan, 570312, China
Hebei
Affiliated Hospital of Hebei University, Baoding, Hebei, 071000, China
Heilongjiang
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, 150000, China
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Hubei
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
Hunan Cancer Hospital, Changsha, Hunan, 410013, China
Jiangsu
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
Jiangxi
The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang, Jiangxi, 330006, China
Jilin
Jilin Cancer Hospital, Changchun, Jilin, 130021, China
The First Hospital of Jilin University, Changchun, Jilin, 130021, China
Liaoning
First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China
Liaoning Cancer Hospital and Institute, Shenyang, Liaoning, 110042, China
Shaanxi
The First Affiliated Hospital of Xian Jiaotong University, Xi'an, Shaanxi, 710061, China
Shandong
Shandong Cancer Hospital, Jinan, Shandong, 250117, China
Weifang Peoples Hospital, Weifang, Shandong, 261000, China
Shanghai Municipality
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
Sichuan
West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China
West China Second University Hospital, Sichuan University, Chengdu, Sichuan, 610101, China
Tianjin Municipality
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
Xinjiang
Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 830000, China
Zhejiang
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
Akita University Hospital, Akitashi, Akita, 010-8543, Japan
Chiba
Chiba Cancer Center, Chiba, Chiba, 260-8717, Japan
Fukuoka
Nho Kyushu Cancer Center, Fukuoka, Fukuoka, 811-1395, Japan
Hokkaido
Hokkaido University Hospital, Sapporo, Hokkaido, 060-8648, Japan
Osaka
Izumi City General Hospital, Izumishi, Osaka, 594-0073, Japan
The University of Osaka Hospital, Suitashi, Osaka, 565-0871, Japan
Tokyo
National Cancer Center Hospital, ChuoKu, Tokyo, 104-0045, Japan
University Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital, Kuching, 93586, Malaysia
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia, Gdynia, 81-519, Poland
Centrum Onkologii Instytut Im M Sklodowskiej Curie, Warsaw, 02-781, Poland
Gyeonggi-do
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
Incheon Gwang'yeogsi
Gachon University Gil Medical Center, NamdongGu, Incheon Gwang'yeogsi, 21565, South Korea
Jeollanam-do
Chonnam National University Hwasun Hospital, HwasunGun, Jeollanam-do, 58128, South Korea
Seoul Teugbyeolsi
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
China Medical University Hospital, North Dist, 404327, Taiwan
National Cheng Kung University Hospital, North Dist, 704, 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)