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

NCT ID: NCT04164199

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Advanced Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Surzebiclimab

Intervention Type DRUG

Administered intravenously.

LBL-007

Intervention Type DRUG

Administered intravenously.

P - Tislelizumab and Zanidatamab Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Zanidatamab

Intervention Type DRUG

Administered intravenously.

Q - Tislelizumab and LBL-007 Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

LBL-007

Intervention Type DRUG

Administered intravenously.

A - Tislelizumab Monotherapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

B - Pamiparib Monotherapy

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered orally.

C - Sitravatinib Monotherapy

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Administered orally.

D - BGB-15025 Monotherapy

Group Type EXPERIMENTAL

BGB-15025

Intervention Type DRUG

Administered orally.

E - Zanidatamab Monotherapy

Group Type EXPERIMENTAL

Zanidatamab

Intervention Type DRUG

Administered intravenously.

F - Pamiparib and Temozolomide Combination Therapy

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered orally.

Temozolomide

Intervention Type DRUG

Administered orally.

G - Tislelizumab and Pamiparib Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Pamiparib

Intervention Type DRUG

Administered orally.

H - Tislelizumab and Sitravatinib Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Sitravatinib

Intervention Type DRUG

Administered orally.

I - Tislelizumab and Ociperlimab Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Ociperlimab

Intervention Type DRUG

Administered intravenously.

J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

BAT1706

Intervention Type DRUG

Administered intravenously.

K - Tislelizumab and Fruquintinib Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Fruquintinib

Intervention Type DRUG

Administered orally.

L - Tislelizumab and BGB-A445 Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

BGB-A445

Intervention Type DRUG

Administered intravenously.

M - Tislelizumab and Surzebiclimab Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Surzebiclimab

Intervention Type DRUG

Administered intravenously.

N - Tislelizumab and BGB-15025 Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

BGB-15025

Intervention Type DRUG

Administered orally.

O - Tislelizumab and Lenvatinib Combination Therapy

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously.

Lenvatinib

Intervention Type DRUG

Administered orally.

Interventions

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Tislelizumab

Administered intravenously.

Intervention Type DRUG

Pamiparib

Administered orally.

Intervention Type DRUG

Temozolomide

Administered orally.

Intervention Type DRUG

Sitravatinib

Administered orally.

Intervention Type DRUG

Ociperlimab

Administered intravenously.

Intervention Type DRUG

BAT1706

Administered intravenously.

Intervention Type DRUG

Fruquintinib

Administered orally.

Intervention Type DRUG

BGB-15025

Administered orally.

Intervention Type DRUG

Zanidatamab

Administered intravenously.

Intervention Type DRUG

BGB-A445

Administered intravenously.

Intervention Type DRUG

Surzebiclimab

Administered intravenously.

Intervention Type DRUG

Lenvatinib

Administered orally.

Intervention Type DRUG

LBL-007

Administered intravenously.

Intervention Type DRUG

Other Intervention Names

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BGB-A317 BGB-290 BGB-A1217 ZW25 Gimistotug BGB-A425 Alcestobart

Eligibility Criteria

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Inclusion Criteria

1. Currently participating in a BeiGene-sponsored eligible parent study
2. Fulfills treatment criteria specified in the parent study protocol
3. In the opinion of the investigator, the participant will continue to benefit from and tolerate any of the parent study treatments.
4. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study:

1. "Treatment interruption" (unplanned pause in study treatment) and "treatment break" (planned stop of study therapy) are not interchangeable. Restarting study treatment beyond the interruption period allowed by the parent study or after a treatment break will be determined by the investigator and the sponsor. Participants who have not restarted treatment within 1 year of starting a treatment break must discontinue treatment.


1. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion
2. Parent study plans to have survival analysis

Exclusion Criteria

1. Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
2. Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study
3. Have a life-threatening illness, 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
4. 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
5. Pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Site Status

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Northern Cancer Institute

St Leonards, New South Wales, Australia

Site Status

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Site Status

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Site Status

Monash Health

Clayton, Victoria, Australia

Site Status

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

The Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

Site Status

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

Guangzhou, Guangdong, China

Site Status

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

The Fifth Affiliated Hospital Sun Yat Sen University

Zhuhai, Guangdong, China

Site Status

The Peoples Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status

The Second Affiliated Hospital of Zunyi Medical University

Zuiyi, Guizhou, China

Site Status

Hainan Cancer Hospital

Haikou, Hainan, China

Site Status

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Site Status

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

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

Wuhan, Hubei, China

Site Status

Zhongnan Hospital of Wuhan University Wuhan

Wuhan, Hubei, China

Site Status

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Site Status

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Site Status

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status

Weifang Peoples Hospital

Weifang, Shandong, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

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

Shanghai, Shanghai Municipality, China

Site Status

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

The First Provincial Wenzhou Hospital of Zhejiang

Wenzhou, Zhejiang, China

Site Status

Hopital Beaujon

Clichy, , France

Site Status

Hopital Prive Jean Mermoz

Lyon, , France

Site Status

Icm Val Daurelle

Montpellier, , France

Site Status

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, , France

Site Status

Hopital Larchet Chu Nice

Nice, , France

Site Status

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, , Italy

Site Status

Aou Pisana, Stabilimento Di Santa Chiara

Pisa, , Italy

Site Status

Azienda Ospedaliera S Maria Di Terni

Terni, , Italy

Site Status

Akita University Hospital

Akitashi, Akita, Japan

Site Status

Chiba Cancer Center

Chiba, Chiba, Japan

Site Status

Nho Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Izumi City General Hospital

Izumishi, Osaka, Japan

Site Status

The University of Osaka Hospital

Suitashi, Osaka, Japan

Site Status

National Cancer Center Hospital

ChuoKu, Tokyo, Japan

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Sarawak General Hospital

Kuching, , Malaysia

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

Gdynia, , Poland

Site Status

Centrum Onkologii Instytut Im M Sklodowskiej Curie

Warsaw, , Poland

Site Status

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Site Status

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

Site Status

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, South Korea

Site Status

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, South Korea

Site Status

Chonnam National University Hwasun Hospital

HwasunGun, Jeollanam-do, South Korea

Site Status

Smg Snu Boramae Medical Center

DongjakGu, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Site Status

Korea University Guro Hospital

GuroGu, Seoul Teugbyeolsi, South Korea

Site Status

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Site Status

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

Chiayi Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital

Guishan Dist, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Niaosong Dist, , Taiwan

Site Status

China Medical University Hospital

North Dist, , Taiwan

Site Status

National Cheng Kung University Hospital

North Dist, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Chi Mei Medical Center

Yongkang Dist, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital (Chulalongkorn University)

Pathum Wan, , Thailand

Site Status

Acibadem Adana Hospital

Kuruköprü, , Turkey (Türkiye)

Site Status

Bakirkoy Sadi Konuk Eah

stanbulBakrkoy, , Turkey (Türkiye)

Site Status

Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

Site Status

Countries

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United States Australia China France Italy Japan Malaysia New Zealand Poland South Korea Taiwan Thailand Turkey (Türkiye)

Other Identifiers

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2019-002554-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BGB-A317-290-LTE1

Identifier Type: -

Identifier Source: org_study_id