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To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05014828
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : May 23, 2023
Information provided by (Responsible Party):

Brief Summary:
This study includes 2 parts. Part 1 is a safety run-in stage and part 2 is to assess the efficacy and safety of tislelizumab in combination with lenvatinib

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: lenvatinib Drug: Tislelizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 18, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Lenvatinib

Arm Intervention/treatment
Experimental: Safety Run in Stage and Combination Assessment
lenvatinib + tislelizumab
Drug: lenvatinib
Capsules administered orally

Drug: Tislelizumab
intravenous (iv) infusion
Other Name: BGB-A317

Primary Outcome Measures :
  1. Part 1: Percentage of Participants Reporting One or More Dose-Limiting Toxicities (DLTs) Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 28 days in Part 1 ]
  2. Part 1: Number of Participants with Clinically Significant physical examinations, electrocardiograms (ECGs), and laboratory assessments [ Time Frame: Up to 28 days in Part 1 ]
  3. Part 2: Overall response rate (ORR) [ Time Frame: up to approximately 3.5 years ]
    Defined as the proportion of participants who achieved complete response (CR), or partial response (PR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: up to approximately 3.5 years ]
    PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first

  2. Duration Of Response (DOR) [ Time Frame: up to approximately 3.5 years ]
    DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death

  3. Disease Control Rate (DCR) [ Time Frame: up to approximately 3.5 years ]
    DCR is defined as the percentage of participants who have shown Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as the best overall response in accordance with the RECIST version 1.1 criteria.

  4. Overall Survival (OS) [ Time Frame: up to approximately 3.5 years ]
    OS defined as the time from start of treatment to the date of death due to any cause

  5. Part 2: Proportion of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: up to approximately 3.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key inclusion criteria:

  1. Signed informed consent form (ICF) and able to comply with study requirements
  2. Histologically and/or cytologically confirmed advanced solid tumor types such as one of following: Non-small cell lung cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Colorectal Cancer (UC), or Renal Cell Carcinoma (RCC).
  3. At least 1 measurable lesion per RECIST version 1.1
  4. Tumor tissue (approximately 10 unstained slides) for central laboratory assessment of pd-l1 status for the NSCLC cohort during the screening period, and for retrospective analysis of other exploratory biomarkers related to response and resistance for NSCLC, SCCHN, UC, or GC cohorts in a BeiGene designated central or test laboratory.
  5. ECOG performance status ≤ 1

Key exclusion criteria:

  1. For the NSCLC cohort, active leptomeningeal disease or uncontrolled, untreated brain metastasis will be excluded. For other cohorts than NSCLC, patients with known leptomeningeal disease or brain metastasis will be excluded.
  2. Prior therapy with lenvatinib or an anti-pd-1, anti-pd-l1, anti-pd-l2 or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways
  3. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
  4. Inability to swallow capsules or disease/procedure significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
  5. Have clinically significant bleeding (such as ctcae ≥ grade 2) within 21 days before first dose


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014828

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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

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China, Anhui
The Second Hospital of Anhui Medical Hospital Recruiting
Hefei, Anhui, China, 230601
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Beijing Luhe Hospital Recruiting
Beijing, Beijing, China, 101100
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Peking University First Hospital Recruiting
Beijing, Beijing, China
China, Chongqing
Chongqing University Cancer Hospital Recruiting
Chongqing, Chongqing, China, 400030
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530021
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
China, Hubei
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430023
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School Not yet recruiting
Nanjing, Jiangsu, China
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
China, Zhejiang
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05014828    
Other Study ID Numbers: BGB-A317-212
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Solid tumors
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological