Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03666143




Registration number
NCT03666143
Ethics application status
Date submitted
21/08/2018
Date registered
11/09/2018
Date last updated
24/03/2023

Titles & IDs
Public title
A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.
Scientific title
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
CTR20181404
Secondary ID [2] 0 0
BGB-900-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitravatinib
Treatment: Drugs - Tislelizumab

Experimental: Anti-PD-1/PD-L1 antibody refractory/resistant NSCLC -

Experimental: Anti-PD-1/PD-L1 antibody naïve NSCLC -

Experimental: Anti-PD-1/PD-L1 antibody refractory/resistant RCC -

Experimental: Metastatic or advanced RCC without prior systemic therapy -

Experimental: Anti-PD-1/PD-L1 naïve recurrent / platinum resistant OC -

Experimental: Anti-PD-1/PD-L1 treated metastatic, squamous NSCLC -

Experimental: Anti-PD-1/PD-L1 antibody R/R melanoma -

Experimental: PD-L1 positive, naïve, advanced or metastatic, non-sq NSCLC -

Experimental: PD-L1 positive, naïve, advanced or metastatic, sq NSCLC -


Treatment: Drugs: Sitravatinib
120 mg orally once daily in combination with tislelizumab

Treatment: Drugs: Tislelizumab
200 mg IV once every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs) per NCI-CTCAE version 5.0
Timepoint [1] 0 0
All AEs and SAEs will be reported until either 30 days after last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first. Immune-related should be reported until 90 days after the last dose of tislelizumab

Eligibility
Key inclusion criteria
1. Able to provide written informed consent and can understand and agree to comply with
the requirements of the study and the Schedule of Assessments

2. Age = 18 years on the day of signing the informed consent form (or the legal age of
consent in the jurisdiction in which the study is taking place)

3. At least 1 measurable lesion as defined by RECIST v1.1

4. Provide archival tumor tissue (formalin-fixed paraffin-embedded block [FFPE] with
tumor tissue or unstained slides), if available.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1

6. Adequate hematologic and end-organ function

7. Patients with inactive/asymptomatic carrier, chronic, or active hepatitis B virus
(HBV) must have HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at
Screening

8. Females of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study, and = 120 days after the last dose of
study drugs and have a negative serum pregnancy test = 7 days of first dose of study
drugs

9. Non-sterile males must be willing to use a highly effective method of birth control
for the duration of the study and for = 120 days after the last dose of study drugs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment.

2. Active leptomeningeal disease or uncontrolled brain metastasis.

3. Active autoimmune diseases or history of autoimmune diseases that may relapse.

4. Any active malignancy = 2 years

5. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication = 14 days
before first dose of study drugs

6. History of interstitial lung disease, noninfectious pneumonitis or uncontrolled
diseases, including pulmonary fibrosis, acute lung diseases, etc.

8. Severe chronic or active infections (including tuberculosis infection, etc.) requiring
systemic antibacterial, antifungal or antiviral therapy, within 14 days prior to first dose
of study drugs

9. Known history of HIV infection

10. Patients with active hepatitis C infection.

11. Any major surgical procedure requiring general anesthesia = 28 days before first dose
of study drugs

12. Prior allogeneic stem cell transplantation or organ transplantation

13. Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation,
or to any component of the container

14. Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar
agents requiring therapeutic INR monitoring within 6 months before first dose of study
drugs

15. Concurrent participation in another therapeutic clinical trial

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2023
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
ICON Cancer Foundation - South Brisbane
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Monash Health - Melbourne
Recruitment hospital [5] 0 0
Nucleus Network - Melbourne
Recruitment hospital [6] 0 0
Linear Clinical Research Limited - Perth
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Jilin
Country [4] 0 0
China
State/province [4] 0 0
Shanghai
Country [5] 0 0
China
State/province [5] 0 0
Tianjin
Country [6] 0 0
China
State/province [6] 0 0
Zhejiang

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, non-randomized Phase 1b clinical trial for patients with
histologically or cytologically confirmed locally advanced or metastatic tumors including
non-squamous or squamous NSCLC, RCC, OC, or melanoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03666143
Trial related presentations / publications
Guo J, Zhou Q, Huang D, Yu X, Zhao J, Chu Q, Ma Z, Millward M, Gao B, Goh J, Markman B, Voskoboynik M, Gan H, Coward J, Chen C, Xiang X, Qui J, Xu Y, Yang L, Wu YL. A phase 1b study to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity of sitravatinib in combination with tislelizumab in patients (pts) with advanced solid tumors. Chinese Society of Clinical Oncology. 2019.
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/ct2/show/NCT03666143