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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
28/10/2024

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
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Pamiparib
Treatment: Drugs - Temozolomide
Treatment: Drugs - Sitravatinib
Treatment: Drugs - Ociperlimab
Treatment: Drugs - BAT1706
Treatment: Drugs - Fruquintinib
Treatment: Drugs - BGB-15025
Treatment: Drugs - Zanidatamab
Treatment: Drugs - BGB-A445
Treatment: Drugs - Surzebiclimab
Treatment: Drugs - Lenvatinib
Treatment: Drugs - LBL-007

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 -

Experimental: H - Tislelizumab and Sitravatinib Combination Therapy -

Experimental: I - Tislelizumab and Ociperlimab Combination Therapy -

Experimental: J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy -

Experimental: K - Tislelizumab and Fruquintinib Combination Therapy -

Experimental: L - Tislelizumab and BGB-A445 Combination Therapy -

Experimental: M - Tislelizumab and Surzebiclimab Combination Therapy -

Experimental: N - Tislelizumab and BGB-15025 Combination Therapy -

Experimental: O - Tislelizumab and Lenvatinib Combination Therapy -

Experimental: P - Tislelizumab and Zanidatamab Combination Therapy -

Experimental: Q - Tislelizumab and LBL-007 Combination Therapy -

Experimental: R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy -


Treatment: Drugs: Tislelizumab
Administered intravenously.

Treatment: Drugs: Pamiparib
Administered orally.

Treatment: Drugs: Temozolomide
Administered orally.

Treatment: Drugs: Sitravatinib
Administered orally.

Treatment: Drugs: Ociperlimab
Administered intravenously.

Treatment: Drugs: BAT1706
Administered intravenously.

Treatment: Drugs: Fruquintinib
Administered orally.

Treatment: Drugs: BGB-15025
Administered orally.

Treatment: Drugs: Zanidatamab
Administered intravenously.

Treatment: Drugs: BGB-A445
Administered intravenously.

Treatment: Drugs: Surzebiclimab
Administered intravenously.

Treatment: Drugs: Lenvatinib
Administered orally.

Treatment: Drugs: LBL-007
Administered intravenously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Immune-Mediated Adverse Events
Timepoint [1] 0 0
up to 7 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
up to 7 years

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)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
China
State/province [5] 0 0
Anhui
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Chongqing
Country [8] 0 0
China
State/province [8] 0 0
Fujian
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Guangxi
Country [11] 0 0
China
State/province [11] 0 0
Guizhou
Country [12] 0 0
China
State/province [12] 0 0
Hainan
Country [13] 0 0
China
State/province [13] 0 0
Hebei
Country [14] 0 0
China
State/province [14] 0 0
Heilongjiang
Country [15] 0 0
China
State/province [15] 0 0
Henan
Country [16] 0 0
China
State/province [16] 0 0
Hubei
Country [17] 0 0
China
State/province [17] 0 0
Hunan
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Jiangxi
Country [20] 0 0
China
State/province [20] 0 0
Jilin
Country [21] 0 0
China
State/province [21] 0 0
Liaoning
Country [22] 0 0
China
State/province [22] 0 0
Shaanxi
Country [23] 0 0
China
State/province [23] 0 0
Shandong
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Sichuan
Country [26] 0 0
China
State/province [26] 0 0
Tianjin
Country [27] 0 0
China
State/province [27] 0 0
Xinjiang
Country [28] 0 0
China
State/province [28] 0 0
Zhejiang
Country [29] 0 0
France
State/province [29] 0 0
Clichy
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Montpellier
Country [32] 0 0
France
State/province [32] 0 0
Nantes Cedex
Country [33] 0 0
France
State/province [33] 0 0
Nice
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
State/province [35] 0 0
Pisa
Country [36] 0 0
Italy
State/province [36] 0 0
Terni
Country [37] 0 0
Japan
State/province [37] 0 0
Akita
Country [38] 0 0
Japan
State/province [38] 0 0
Chiba
Country [39] 0 0
Japan
State/province [39] 0 0
Fukuoka
Country [40] 0 0
Japan
State/province [40] 0 0
Hokkaido
Country [41] 0 0
Japan
State/province [41] 0 0
Osaka
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Gyeonggi-do
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Incheon Gwang'yeogsi
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul Teugbyeolsi
Country [46] 0 0
New Zealand
State/province [46] 0 0
Auckland
Country [47] 0 0
Poland
State/province [47] 0 0
Gdynia
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Taiwan
State/province [49] 0 0
Chiayi
Country [50] 0 0
Taiwan
State/province [50] 0 0
Kaohsiung
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taichung City
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taichung
Country [53] 0 0
Taiwan
State/province [53] 0 0
Tainan
Country [54] 0 0
Taiwan
State/province [54] 0 0
Taoyuan
Country [55] 0 0
Turkey
State/province [55] 0 0
Adana
Country [56] 0 0
Turkey
State/province [56] 0 0
stanbulBakrkoy
Country [57] 0 0
Turkey
State/province [57] 0 0
Tekirdag

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

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04164199
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04164199