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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04164199




Registration number
NCT04164199
Ethics application status
Date submitted
14/11/2019
Date registered
15/11/2019
Date last updated
9/11/2023

Titles & IDs
Public title
Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies
Scientific title
An Open Label, Multicentre, Long-Term Extension Study of Tislelizumab- Containing Treatment and/or Pamiparib-Containing Treatment 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 - Pemetrexed 500 mg/m² IV
Treatment: Drugs - Capecitabine 1000 mg/m² PO BID
Treatment: Drugs - Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)
Treatment: Drugs - Sitravatinib
Treatment: Drugs - Ociperlimab
Treatment: Drugs - BAT1706
Treatment: Drugs - Fruquintinib

Experimental: Tislelizumab monotherapy -

Experimental: Pamiparib Monotherapy -

Experimental: Tislelizumab and Pamiparib Combination Therapy -

Experimental: Tislelizumab and Pemetrexed Combination Therapy -

Experimental: Tislelizumab and Capecitabine Combination Therapy -

Experimental: Pamiparib and temozolomide Combination Therapy -

Experimental: Sitravatinib Monotherapy -

Experimental: Tislelizumab and Sitravatinib Combination Therapy -

Experimental: Tislelizumab and Ociperlimab Combination Therapy -

Experimental: Tislelizumab and BAT1706 Combination Therapy -

Experimental: Tislelizumab and Fruquintinib Combination Therapy -


Treatment: Drugs: Tislelizumab
To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.

Treatment: Drugs: Pamiparib
To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.

Treatment: Drugs: Pemetrexed 500 mg/m² IV
To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.

Treatment: Drugs: Capecitabine 1000 mg/m² PO BID
Day 1 to Day 15 of each 21 day cycle, to be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.

Treatment: Drugs: Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)
To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.

Treatment: Drugs: Sitravatinib
To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.

Treatment: Drugs: Ociperlimab
Participants will receive tislelizumab followed by the administration of ociperlimab on Day 1 of each 21-day cycle (ie, once every 3 weeks)

Treatment: Drugs: BAT1706
Participants will receive tislelizumab followed by the administration of BAT1706 on Day 1 of each 21-day cycle (ie, once every 3 weeks). If applicable, ociperlimab will be administered after completion of the BAT1706 infusion

Treatment: Drugs: Fruquintinib
Fruquintinib will be self-administered orally once daily for 21 days, followed by 7 days off in 28-day cycles with or without food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of all adverse events
Timepoint [1] 0 0
up to 5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
up to 5 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
tislelizumab and 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.

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. For tislelizumab monotherapy or in combination with chemotherapies, the
interruption period is no more than 12 weeks

2. 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

3. 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

4. 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

5. 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:

1. Signed informed consent obtained prior to enrolling in this LTE study

2. Currently participating in a BeiGene-sponsored eligible parent study in the survival
follow-up portion following tislelizumab-containing therapy

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 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

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 tislelizumab or pamiparib, 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
1/08/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Chongqing
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Guangxi
Country [7] 0 0
China
State/province [7] 0 0
Guizhou
Country [8] 0 0
China
State/province [8] 0 0
Hainan
Country [9] 0 0
China
State/province [9] 0 0
Heilongjiang
Country [10] 0 0
China
State/province [10] 0 0
Henan
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Jiangxi
Country [15] 0 0
China
State/province [15] 0 0
Jilin
Country [16] 0 0
China
State/province [16] 0 0
Liaoning
Country [17] 0 0
China
State/province [17] 0 0
Shaanxi
Country [18] 0 0
China
State/province [18] 0 0
Shandong
Country [19] 0 0
China
State/province [19] 0 0
Shanghai
Country [20] 0 0
China
State/province [20] 0 0
Sichuan
Country [21] 0 0
China
State/province [21] 0 0
Tianjin
Country [22] 0 0
China
State/province [22] 0 0
Xinjiang
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
Country [25] 0 0
Taiwan
State/province [25] 0 0
Kaohsiung
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taichung
Country [27] 0 0
Taiwan
State/province [27] 0 0
Tainan
Country [28] 0 0
Turkey
State/province [28] 0 0
Adana
Country [29] 0 0
Turkey
State/province [29] 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 of
tislelizumab or pamiparib given either as monotherapy or in combination with each other or
with other agents in participants with advanced malignancies who participated in a prior
BeiGene sponsored clinical study (parent study).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04164199
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Andong Nkobena Florinas, Pharm. D.
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/ct2/show/NCT04164199