Clinical trial NCT05014828: To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Solid Tumor
Keywords: Solid tumors
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Percentage of Participants Reporting One or More Dose-Limiting Toxicities (DLTs) Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 28 days in Part 1
measure: Part 1: Number of Participants with Clinically Significant physical examinations, electrocardiograms (ECGs), and laboratory assessments
timeFrame: Up to 28 days in Part 1
measure: Part 2: Overall response rate (ORR)
timeFrame: up to approximately 3.5 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: up to approximately 3.5 years
measure: Duration Of Response (DOR)
timeFrame: up to approximately 3.5 years
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 3.5 years
measure: Overall Survival (OS)
timeFrame: up to approximately 3.5 years
measure: Part 2: Proportion of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: up to approximately 3.5 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Nanning
country: China
facility: The Peoples Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Cancer Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Hangzhou
country: China
facility: Zhejiang Provincial Peoples Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: