To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors
- Registration Number
- NCT05014828
- Lead Sponsor
- BeiGene
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Safety Run in Stage and Combination Assessment lenvatinib lenvatinib + tislelizumab Safety Run in Stage and Combination Assessment Tislelizumab lenvatinib + tislelizumab
- Primary Outcome Measures
Name Time Method 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 Part 1: Number of Participants with Clinically Significant physical examinations, electrocardiograms (ECGs), and laboratory assessments Up to 28 days in Part 1 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
Name Time Method 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
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
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.
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
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
Trial Locations
- Locations (16)
The Second Hospital of Anhui Medical Hospital
🇨🇳Hefei, Anhui, China
Beijing Luhe Hospital
🇨🇳Beijing, Beijing, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China