The primary purpose of this study is to assess the safety and tolerability of ociperlimab (BGB-A1217) in combination with tislelizumab (BGB-A317) or rituximab in participants with relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
administered intravenously
Administered intravenously once every 3 weeks
Administered intravenously once every 3 weeks
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug(s), whether considered related to study drug(s) or not. An SAE is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement (eg, may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).
Time frame: From first dose of study drug up to 30 days after last dose, maximum time on treatment was 98 weeks.
Recommended Phase 2 Dose (RP2D) of Ociperlimab When Administered in Combination With Tislelizumab or Rituximab
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33.3%
Time frame: 21 days
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) based on the Lugano classification as assessed by the investigator. Response was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDGPET). CR: complete metabolic (no/minimal FDG uptake and no evidence of FDG-avid disease in bone marrow) and radiologic response (target lesions regressed to ≤ 1.5 cm in longest diameter with no extra-lymphatic sites of disease, no organ enlargement and normal bone marrow morphology), no new lesions, and no bone marrow involvement confirmed by bone marrow biopsies (if bone marrow was involved at baseline). PR is partial metabolic (reduced FDG uptake from Baseline) and radiologic response (≥ 50% decrease in size of measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \> 50% in length beyond normal) and no new lesions.
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
...and 9 more locations
Time frame: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.
Complete Response Rate (CRR)
CRR is defined as the percentage of participants who achieved a complete response per the Lugano Classification (2014) as assessed by the investigator.
Time frame: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.
Duration of Response (DOR)
DOR is defined as the time from the date that response criteria were first met to the date that progressive disease is objectively documented per Lugano Classification (2014), as assessed by the investigator, or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
Time frame: Up to the data cutoff date of 30 August 2024; maximum time on study was 28 months.
Time to Response (TTR)
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) per Lugano Classification (2014) as assessed by the investigator
Time frame: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.
Progression-free Survival (PFS)
PFS is defined as the time from first dose until first documentation of progression per Lugano Classification (2014), as assessed by the investigator, or death, whichever comes first. Median PFS was estimated using the Kaplan-Meier method.
Time frame: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.
Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Time frame: From first dose of study drug to the data cutoff date of 30 August 2024; maximum time on study was 28 months.
Serum Concentration of Ociperlimab
Time frame: Predose and end of infusion (EOI) on Cycle 1 Day 1 (C1D1), Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, and Cycle 17 Day 1
Host Immunogenicity: Number of Participants With Anti-drug Antibodies (ADA) to Ociperlimab
The number of participants with anti-drug antibodies to ociperlimab includes participants that were ADA-negative at Baseline and ADA-positive after drug administration during the treatment or follow-up observation period and participants who were positive at Baseline for ADA and with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period.
Time frame: From first dose of study treatment to 30 days after last dose; maximum time on treatment was 98 weeks