Clinical Trials List
2020-04-01 - 2026-05-01
Phase III
Not yet recruiting4
Recruiting3
Terminated2
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies
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Trial Applicant
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Sponsor
BeiGene
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 劉奕廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳彥仰 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Shau-Hsuan Li 無
- Yu-Li Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chen-Chun Lin 無
- Hung-Chih Hsu 無
- Po-Jung Su Division of Hematology & Oncology
- Tsai-Sheng Yang Division of Hematology & Oncology
- 陳冠仁 無
- 張鈞弼 無
- Wen-Chi Chou Division of Hematology & Oncology
- 呂嘉偉 無
- Jen-Shi Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 劉家豪 Division of Hematology & Oncology
- Sheng-chieh Chou Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 陳威宇 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
BGB-A317 (Tislelizumab)
Dosage Form
capsule
Dosage
20mg/capsule
Endpoints
Incidence of all adverse events [ Time Frame: up to 5 years ]
Safety as assessed by incidence of all adverse events of special interest, Grade 3, 4, or 5 adverse events, Grade 2 adverse events that affect vital organs (eg, heart, liver), nonserious adverse events that lead to dose modification or drug discontinuation or withdrawal from the trial, and serious adverse events of any severity.
Secondary Outcome Measures :
Overall survival [ Time Frame: up to 5 years ]
Overall survival defined as the time from start of treatment in parent study (or randomization date for a randomized study) until the date of death from any cause.
Inclution Criteria
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 tislelizumab and/or pamiparib treatment as monotherapy or in combination.
Note: For patients with GBM, continuation on single agent pamiparib or single agent temozolomide will not be permitted.
Note: For patients with solid tumors (other than GBM), receiving single agent pamiparib is allowed if deemed clinically appropriate by the investigator. Continued treatment with single agent temozolomide will not be permitted.
The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study:
For tislelizumab monotherapy or in combination with chemotherapies, the interruption period is no more than 12 weeks
For pamiparib monotherapy, interruption period is no more than 21 consecutive days due to toxicities other than anaemia and no more than 56 consecutive days for investigational drug-related anaemia
For pamiparib in combination with tislelizumab, the interruption period is no more than 21 consecutive days for pamiparib and no more than 42 consecutive days for tislelizumab
For pamiparib in combination with low dose temozolomide, the interruption period is no more than 28 consecutive days due to toxicities other than anaemia and no more than 56 consecutive days for investigational drug-related anaemia
If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the medical monitor of the LTE study
Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study:
Signed informed consent obtained prior to enrolling in this LTE study
Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion following tislelizumab-containing therapy
Exclusion Criteria
Permanently discontinued from either tislelizumab and/or pamiparib treatment in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent. Participants who were treated with pamiparib or tislelizumab in combination with other agents and are still receiving pamiparib or tislelizumab but have discontinued the other agent(s) are eligible with the exception of patients with GBM receiving the combination of pamiparib and low-dose temozolomide
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 tislelizumab or pamiparib, 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
The Estimated Number of Participants
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Taiwan
16 participants
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Global
400 participants
