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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04164199




Registration number
NCT04164199
Ethics application status
Date submitted
14/11/2019
Date registered
15/11/2019
Date last updated
20/08/2024

Titles & IDs
Public title
Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
Scientific title
An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies
Secondary ID [1] 0 0
2019-002554-23
Secondary ID [2] 0 0
BGB-A317-290-LTE1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancies 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: A - Tislelizumab Monotherapy -

Experimental: B - Pamiparib Monotherapy -

Experimental: C - Sitravatinib Monotherapy -

Experimental: D - BGB-15025 Monotherapy -

Experimental: E - Zanidatamab Monotherapy -

Experimental: F - Pamiparib and Temozolomide Combination Therapy -

Experimental: G - Tislelizumab and Pamiparib Combination Therapy -

Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04164199