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

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05014828
Collaborator
(none)
150
Enrollment
16
Locations
1
Arm
38.4
Anticipated Duration (Months)
9.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 18, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Safety Run in Stage and Combination Assessment

lenvatinib + tislelizumab

Drug: lenvatinib
Capsules administered orally

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

    		•

    Outcome Measures

    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) [Up to 28 days in Part 1]

    2. Part 1: Number of Participants with Clinically Significant physical examinations, electrocardiograms (ECGs), and laboratory assessments [Up to 28 days in Part 1]

    3. Part 2: Overall response rate (ORR) [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) [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) [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) [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) [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) [up to approximately 3.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    NOTE: OTHER PROTOCOL DEFINED INCLUSION/EXCLUSION CRITERIA MAY APPLY

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Hospital of Anhui Medical Hospital Hefei Anhui China 230601
    2 Beijing Cancer Hospital Beijing Beijing China 100142
    3 Beijing Luhe Hospital Beijing Beijing China 101100
    4 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China
    5 Peking University First Hospital Beijing Beijing China
    6 Chongqing University Cancer Hospital Chongqing Chongqing China 400030
    7 The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi China 530021
    8 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    9 Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430023
    10 Hunan Cancer Hospital Changsha Hunan China 410013
    11 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009
    12 Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu China
    13 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China 310014
    14 Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    15 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    16 The First Affiliated Hospital of Nanchang University Nanchang China 330006

    Sponsors and Collaborators

    • BeiGene

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT05014828
    Other Study ID Numbers:
    • BGB-A317-212
    First Posted:
    Aug 20, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Neoplasms
    Lenvatinib

    Study Results

    No Results Posted as of Oct 7, 2021