Zanubrutinib (BGB-3111) in Combination With Tislelizumab (BGB-A317) in Participants With B-cell Malignancies
- Registration Number
- NCT02795182
- Lead Sponsor
- BeiGene
- Brief Summary
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with BGB-A317 in participants with B-cell lymphoid malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanubrutinib abd Tislelizumab Zanubrutinib Based on results of the dose escalation cohorts and the identified recommended Phase 2 dose, all patients will receive zanubrutinib at 160 mg orally twice daily in combination with intravenous infusion of tislelizumab 200mg given every 21 days, to be continued until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination Zanubrutinib abd Tislelizumab Tislelizumab Based on results of the dose escalation cohorts and the identified recommended Phase 2 dose, all patients will receive zanubrutinib at 160 mg orally twice daily in combination with intravenous infusion of tislelizumab 200mg given every 21 days, to be continued until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination
- Primary Outcome Measures
Name Time Method Dose Escalation: RP2D of Tislelizumab From the date of first dose of study drugs until final R2PD was decided (Approximately 1 year and 10 months) The RP2D of tislelizumab in combination with zanubrutinib will be selected by taking into account the safety, tolerability, and pharmacokinetic (PK) profile.
Dose Escalation: Maximum Tolerated Dose (MTD) of Tislelizumab From the date of first dose of study drugs until RP2D was determined (Approximately 1 year and 10 months) The MTD of tislelizumab is considered the dose level below that at which at least 2 participants (or at least 33%) experience a dose-limiting toxicity (DLT).
- Secondary Outcome Measures
Name Time Method Number of Participants With Anti-Drug Antibodies (ADAs) to Tislelizumab From the day of first dose of study drug until end of study (up to 4 years and 6 months) Number of Participants With TEAEs and SAEs From the day of first dose of study drug until end of study (up to 4 years and 6 months) A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date during the treatment emergent period, defined as from the first dose date of zanubrutinib or tislelizumab (whichever is earlier) through 30 days after the last dose (permanent discontinuation of study drug) of zanubrutinib or 90 days after the last dose of tislelizumab, whichever is later, or prior to initiation of new anti-cancer therapy. Treatment-related serious adverse events (SAEs) and any worsening of a TEAE by PT post treatment-emergent period were also counted as TEAEs.
Overall Response Rate Up to 4 years and 6 months ORR, is defined as the percentage of participants who had complete response (CR) or partial response (PR) by standard disease-specific response criteria. for WM participants ORR includes minor response (MR) and very good partial response (VGPR).
Progression Free Survival (PFS) Up to 4 years and 6 months PFS, is defined as the time from the first dose of study medication to objective disease progression or death
Duration of Response (DOR) Up to 4 years and 6 months DOR is defined as the time from the date that a confirmed objective response is first documented to the date of progressive disease (PD) or death due to any cause for those participants with a confirmed PR or CR.
Trial Locations
- Locations (10)
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Shanghai jiaotong university school of medicine Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Concord Hospital
🇦🇺Sydney, New South Wales, Australia
Epworth Healthcare
🇦🇺Richmond, Victoria, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Monash Hospital
🇦🇺Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia