Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
- Registration Number
- NCT04164199
- Lead Sponsor
- BeiGene
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 430
-
Currently participating in a BeiGene-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" (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.
Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study:
- Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion
- Parent study plans to have survival analysis
Key
- 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 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A - Tislelizumab Monotherapy Tislelizumab - F - Pamiparib and Temozolomide Combination Therapy Temozolomide - B - Pamiparib Monotherapy Pamiparib - C - Sitravatinib Monotherapy Sitravatinib - E - Zanidatamab Monotherapy Zanidatamab - F - Pamiparib and Temozolomide Combination Therapy Pamiparib - G - Tislelizumab and Pamiparib Combination Therapy Pamiparib - G - Tislelizumab and Pamiparib Combination Therapy Tislelizumab - I - Tislelizumab and Ociperlimab Combination Therapy Tislelizumab - J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy Tislelizumab - J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy BAT1706 - K - Tislelizumab and Fruquintinib Combination Therapy Tislelizumab - H - Tislelizumab and Sitravatinib Combination Therapy Tislelizumab - H - Tislelizumab and Sitravatinib Combination Therapy Sitravatinib - K - Tislelizumab and Fruquintinib Combination Therapy Fruquintinib - L - Tislelizumab and BGB-A445 Combination Therapy Tislelizumab - L - Tislelizumab and BGB-A445 Combination Therapy BGB-A445 - M - Tislelizumab and Surzebiclimab Combination Therapy Tislelizumab - N - Tislelizumab and BGB-15025 Combination Therapy Tislelizumab - O - Tislelizumab and Lenvatinib Combination Therapy Lenvatinib - Q - Tislelizumab and LBL-007 Combination Therapy Tislelizumab - M - Tislelizumab and Surzebiclimab Combination Therapy Surzebiclimab - O - Tislelizumab and Lenvatinib Combination Therapy Tislelizumab - P - Tislelizumab and Zanidatamab Combination Therapy Tislelizumab - P - Tislelizumab and Zanidatamab Combination Therapy Zanidatamab - R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy Tislelizumab - R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy Surzebiclimab - N - Tislelizumab and BGB-15025 Combination Therapy BGB-15025 - Q - Tislelizumab and LBL-007 Combination Therapy LBL-007 - R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy LBL-007 - I - Tislelizumab and Ociperlimab Combination Therapy Ociperlimab - D - BGB-15025 Monotherapy BGB-15025 -
- Primary Outcome Measures
Name Time Method Number of Participants with Immune-Mediated Adverse Events up to 7 years Safety as assessed by the number of participants with immune-mediated adverse events related to immunotherapy as assessed by the investigator, \> Grade 3 adverse events, Grade 2 adverse events that affect key organs (eg, heart, liver, brain, lung, kidney, eye), nonserious adverse events that lead to dose modification or drug discontinuation or withdrawal from the trial, and serious adverse events.
- Secondary Outcome Measures
Name Time Method Overall survival up to 7 years Overall survival defined as the time from start of treatment in the parent study (or randomization date for a randomized parent study) until the date of death from any cause.
Trial Locations
- Locations (106)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Memorial Sloan Kettering Cancer Center Mskcc
🇺🇸New York, New York, United States
Tennessee Oncology, Pllc Nashville
🇺🇸Nashville, Tennessee, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Northern Cancer Institute
🇦🇺St Leonards, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Icon Cancer Centre South Brisbane
🇦🇺South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Peter Maccallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
The Affiliated Hospital of Military Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
🇨🇳Guangzhou, Guangdong, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Fifth Affiliated Hospital Sun Yat Sen University
🇨🇳Zhuhai, Guangdong, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
The Second Affiliated Hospital of Zunyi Medical University
🇨🇳Zuiyi, Guizhou, China
Hainan Cancer Hospital
🇨🇳Haikou, Hainan, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University Wuhan
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Peoples Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xian, Shaanxi, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Weifang Peoples Hospital
🇨🇳Weifang, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
West China Second University Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Provincial Wenzhou Hospital of Zhejiang
🇨🇳Wenzhou, Zhejiang, China
Hopital Beaujon
🇫🇷Clichy, France
Hopital Prive Jean Mermoz
🇫🇷Lyon, France
Icm Val Daurelle
🇫🇷Montpellier, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
🇫🇷Nantes, France
Hopital Larchet Chu Nice
🇫🇷Nice, France
Policlinico Sorsola Malpighi, Aou Di Bologna
🇮🇹Bologna, Italy
Aou Pisana, Stabilimento Di Santa Chiara
🇮🇹Pisa, Italy
Azienda Ospedaliera S Maria Di Terni
🇮🇹Terni, Italy
Akita University Hospital
🇯🇵Akitashi, Akita, Japan
Chiba Cancer Center
🇯🇵Chibashi, Chiba, Japan
Nho Kyushu Cancer Center
🇯🇵FukuokaShi, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporoshi, Hokkaido, Japan
Izumi City General Hospital
🇯🇵Izumishi, Osaka, Japan
The University of Osaka Hospital
🇯🇵Suitashi, Osaka, Japan
National Cancer Center Hospital
🇯🇵ChuoKu, Tokyo, Japan
Cha Bundang Medical Center, Cha University
🇰🇷BundangGu SeongnamSi, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷BundangGu SeongnamSi, Gyeonggi-do, Korea, Republic of
National Cancer Center (Korea)
🇰🇷IlsandongGu GoyangSi, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St Vincents Hospital
🇰🇷PaldalGu SuwonSi, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷NamdongGu, Incheon Gwang'yeogsi, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷HwasunGun, Jeollanam-do, Korea, Republic of
Smg Snu Boramae Medical Center
🇰🇷DongjakGu, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
🇰🇷GangnamGu, Seoul Teugbyeolsi, Korea, Republic of
Korea University Guro Hospital
🇰🇷GuroGu, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St Marys Hospital
🇰🇷SeochoGu, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷SeodaemunGu, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
🇰🇷SongpaGu, Seoul Teugbyeolsi, Korea, Republic of
Ajou University Hospital
🇰🇷Suwonsi, Korea, Republic of
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Malaysia
Auckland City Hospital
🇳🇿Auckland, New Zealand
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
🇵🇱Gdynia, Poland
Centrum Onkologii Instytut Im M Sklodowskiej Curie
🇵🇱Warszawa, Poland
Chiayi Chang Gung Memorial Hospital
🇨🇳Chiayi, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Guishan Dist, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Niaosong Dist, Taiwan
China Medical University Hospital
🇨🇳North Dist, Taiwan
National Cheng Kung University Hospital
🇨🇳North Dist, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung City, Taiwan
Chi Mei Medical Center
🇨🇳Yongkang Dist, Taiwan
King Chulalongkorn Memorial Hospital (Chulalongkorn University)
🇹🇭Pathum Wan, Thailand
Acibadem Adana Hospital
🇹🇷Kurukopru, Turkey
Bakirkoy Sadi Konuk Eah
🇹🇷stanbulBakrkoy, Turkey
Namik Kemal University
🇹🇷Tekirdag, Turkey