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

Advanced Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04164199
• Other study ID #: BGB-A317-290-LTE1
• Secondary ID: 2019-002554-23
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: December 19, 2019
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study:

1. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion

2. Parent study plans to have survival analysis

Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• Tislelizumab
Administered intravenously.
• Pamiparib
Administered orally.
• Temozolomide
Administered orally.
• Sitravatinib
Administered orally.
• Ociperlimab
Administered intravenously.
• BAT1706
Administered intravenously.
• Fruquintinib
Administered orally.
• BGB-15025
Administered orally.
• Zanidatamab
Administered intravenously.
• BGB-A445
Administered intravenously.
• Surzebiclimab
Administered intravenously.
• Lenvatinib
Administered orally.
• LBL-007
Administered intravenously.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The First Peoples Hospital of Changzhou	Changzhou	Jiangsu
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	West China Second University Hospital	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)	Guangzhou	Guangdong
China	Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)	Guangzhou	Guangdong
China	Hainan Cancer Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang University College of Medicine Second Affiliated Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The Peoples Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
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	Weifang Peoples Hospital	Weifang	Shandong
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Xian Jiaotong University	Xian	Shaanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The Fifth Affiliated Hospital Sun Yat Sen University	Zhuhai	Guangdong
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Incheon Gwang'yeogsi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnamsi	Gyeonggido
Korea, Republic of	Smg Snu Boramae Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, Seoul St Marys Hospital	Seoul	Seoul Teugbyeolsi
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital Gastroenterology	Taichung City
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
Turkey	Acibadem Adana Hospital	Adana
Turkey	Bakirkoy Sadi Konuk Eah	stanbulBakrkoy
Turkey	Namik Kemal University	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Immune-Mediated Adverse Events	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.	up to 7 years
Secondary	Overall survival	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.	up to 7 years