To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors
A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors
2 other identifiers
interventional
58
1 country
13
Brief Summary
This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. The study included two parts: the first part assessed how safe the drug combination was, and the second part examined how well it worked. A small group of participants initially received the drugs to determine the appropriate dose, and if the treatment was well tolerated, additional participants were treated at that dose. Participants remained on the treatment unless their cancer progressed, they experienced serious side effects, or they chose to stop.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2021
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 20, 2021
CompletedStudy Start
First participant enrolled
September 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2024
CompletedResults Posted
Study results publicly available
August 24, 2025
CompletedAugust 24, 2025
August 1, 2025
2.1 years
July 28, 2021
June 30, 2025
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety Run-in: Number of Participants With Adverse Events (AEs)
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (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. A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator.
From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose.
Overall Response Rate (ORR)
Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)
Secondary Outcomes (5)
Progression Free Survival (PFS)
From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)
Duration of Response (DOR)
From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)
Disease Control Rate (DCR)
From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)
Overall Survival (OS)
From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)
Number of Participants Experiencing Adverse Events (AEs)
From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months)
Study Arms (6)
Safety Run In
EXPERIMENTALParticipants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
Part 2: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Cohort
EXPERIMENTALParticipants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2: Renal Cell Carcinoma (RCC) Cohort
EXPERIMENTALSystemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2: Non-Small Cell Lung Cancer (NSCLC) Cohort
EXPERIMENTALParticipants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
Part 2: Gastric Cancer (GC) Cohort
EXPERIMENTALParticipants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
Part 2: Urothelial Cancer (UC) Cohort
EXPERIMENTALParticipants with cisplatin ineligible, systemic therapy naive advanced UC, were to be treated with tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD). This cohort was closed prior to any participant enrollment based on emerging external data.
Interventions
Administered at the dose of 20 mg orally, once daily.
400 mg administered intravenously on Day 1 of each 42-day cycle
Eligibility Criteria
You may qualify if:
- Participants had signed an informed consent form and were able to comply with all study requirements.
- Participants had a histologically and/or cytologically confirmed diagnosis of advanced solid tumors, which included one of the following types:
- Non-Small Cell Lung Cancer (NSCLC)
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Gastric Cancer (GC)
- Urothelial Carcinoma (UC)
- Renal Cell Carcinoma (RCC)
- Participants had at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- Tumor tissue samples (approximately 10 unstained slides) were provided for central laboratory assessment of programmed death-ligand 1 (PD-L1) expression in the NSCLC cohort during the screening period. These samples were also used for retrospective exploratory biomarker analyses related to treatment response and resistance across the NSCLC, SCCHN, UC, or Gastric Cancer (GC) cohorts, in a central or designated test laboratory approved by BeiGene.
- Participants had an Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
You may not qualify if:
- For participants in the NSCLC cohort, those with active leptomeningeal disease or uncontrolled, untreated brain metastases were excluded. In cohorts other than NSCLC, any participant with known leptomeningeal disease or brain metastases was excluded.
- Participants who had received prior therapy with lenvatinib, or with antibodies targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or any other agents specifically targeting T-cell costimulatory or immune checkpoint pathways, were excluded.
- Participants with a history of interstitial lung disease, non-infectious pneumonitis, or any uncontrolled pulmonary conditions (including but not limited to pulmonary fibrosis or acute lung diseases) were excluded.
- Participants who were unable to swallow capsules, or who had diseases or previous procedures that significantly affected gastrointestinal function such as malabsorption syndrome, surgical resection of the stomach or small bowel, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete bowel obstruction were excluded.
- Participants who had experienced clinically significant bleeding (classified as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events \[CTCAE\]) within 21 days prior to the first dose were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (13)
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Province Cancer Hospital
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Related Publications (1)
BGB-A317-212: A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors. Poster No: 2610 presented at ASCO, Chicago, IL, May 31-June 4, 2024
BACKGROUND
MeSH Terms
Interventions
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 20, 2021
Study Start
September 18, 2021
Primary Completion
October 20, 2023
Study Completion
July 10, 2024
Last Updated
August 24, 2025
Results First Posted
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.