Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer

NCT04727996 | Active Not Recruiting Phase 2

• 1 other identifier: H-2005-156-1126
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is open-label, phase II study enrolling advanced BTC patients who have failed to 1st-line chemotherapy.

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  To assess the efficacy of Sitravatinib and Tislelizumab combination on DCR (disease control rate) in biliary tract cancer patients who have failed to 1st-line chemotherapy

  every 6weeks

Secondary Outcomes (3)

• overall response rate

  every 6weeks

• progression-free survival

  every 6weeks

• overall survival

  every 3months

Study Arms (1)

Sitravatinib/Tislelizumab

EXPERIMENTAL

All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Sitravatinib; Drug: Tislelizumab

Interventions

Sitravatinib DRUG

120 mg will be administered orally once daily

Also known as: MGCD516

Sitravatinib/Tislelizumab

Tislelizumab DRUG

200 mg will be administered intravenously (IV) once every 3 weeks

Also known as: BGB-A317

Sitravatinib/Tislelizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age≥ 20 years at time of study entry 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Life expectancy of ≥ 16weeks 5. Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer 6. Unresectable or recurrent 7. Failed to 1st-line chemotherapy for their advanced BTC, but no more than 2 lines of prior chemotherapy regimen 8. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging \[MRI\] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1.
• \. Body weight \>30kg 10. Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment as defined below:
• Haemoglobin ≥9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L
• Platelet count ≥ 75 x 10 9/L
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN), or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation
• AST and ALT ≤ 3.0 x ULN, or AST and ALT ≤ 5.0 x ULN for patients with documented liver metastases
• Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome)
• International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 x ULN
• Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
• \. 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 12. 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 13. 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

You may not qualify if:

• \. Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment, defined as follows:
• ≥ Grade 3 AE related to anti-PD-1/PD-L1 treatment that did not respond to standard therapy and warranted treatment discontinuation.
• Central nervous system or ocular AE of any grade related to anti-PD-1/PD-L1 Note: Patients with a prior endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
• \. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• Patients with a history of treated and, at the time of screening, asymptomatic CNS metastases are eligible, provided they meet all the following:
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• Brain imaging at screening shows no evidence of interim progression
• All brain metastases with supratentorial location
• No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
• No stereotactic radiation or whole-brain radiation within 14 days prior to first dose of study drug(s)
• Patients with new asymptomatic central nervous system metastases detected at the screening scan must receive radiation therapy and/or surgery for central nervous system metastases.
• Following treatment, these patients may then be eligible, provided all other criteria, including those for patients with a history of brain metastases, are met.
• \. Active autoimmune diseases or history of autoimmune diseases that may relapse
• Note: Patients with the following diseases are not excluded and may proceed to further screening:
• Controlled Type I diabetes

Sponsors & Collaborators

• Seoul National University Hospital: lead
• BeiGene: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Yoon J, Lee CK, Kim JW, Kang B, Park SJ, Kim JW, Chon HJ, Choi HJ, Lee MA, Kim TY, Oh DY. Open-label, single-arm, phase II trial to investigate the efficacy of sitravatinib plus tislelizumab combination as a second-line treatment for advanced biliary tract cancer. J Hepatol. 2025 Nov 24:S0168-8278(25)02626-1. doi: 10.1016/j.jhep.2025.10.032. Online ahead of print.

  PMID: 41297674 DERIVED

MeSH Terms

Interventions

sitravatinib; tislelizumab

Study Officials

• Do-Youn Oh, M.D., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: November 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)